Parkinson DiseasePhase 4NCT00321854
Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
A Phase 4 study testing pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim at 99 sites in 10 countries.
Trial summary
This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- pramipexole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 99 sitesin 10 countries
- Study dates
- May 2006to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
- Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
- Parkinsons disease newly diagnosed within the past 2 years;
- Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);
- Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Previous history of allergic response or complications with pramipexole (PPX) or its excipients;
- Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
- The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
- The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;
- If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
- The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease;
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- The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease;
- The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);
- History of stereotactic brain surgery;
- Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study;
- History of active epilepsy (i.e., occurrence of a seizure) within the past year;
- Symptomatic orthostatic hypotension prior to randomization;
- Malignant melanoma or history of previously treated malignant melanoma;
- Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine;
- Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);
- Patients who are currently pregnant or planning pregnancy during the study, or lactating;
- Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;
- History of psychosis;
- A diagnosis of dementia
Trial locations and contacts
99 sites in 10 countries.
99 sites in 10 countries
United States32 sites
248.595.0103 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
248.595.0127 Boehringer Ingelheim Investigational Site
Augusta, Georgia
248.595.0134 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
248.595.0113 Boehringer Ingelheim Investigational Site
Bradenton, Florida
248.595.0122 Boehringer Ingelheim Investigational Site
Brimingham, Alabama
248.595.0101 Boehringer Ingelheim Investigational Site
Chicago, Illinois
248.595.0120 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
248.595.0137 Boehringer Ingelheim Investigational Site
Columbus, Georgia
248.595.0107 Boehringer Ingelheim Investigational Site
Dayton, Ohio
248.595.0111 Boehringer Ingelheim Investigational Site
Elk Grove Village, Illinois
248.595.0105 Boehringer Ingelheim Investigational Site
Gainesville, Florida
248.595.0119 Boehringer Ingelheim Investigational Site
Hollywood, Florida
248.595.0108 Boehringer Ingelheim Investigational Site
Houston, Texas
248.595.0121 Boehringer Ingelheim Investigational Site
Kirkland, Washington
248.595.0133 Boehringer Ingelheim Investigational Site
La Jolla, California
248.595.0140 Boehringer Ingelheim Investigational Site
La Jolla, California
248.595.0116 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
248.595.0112 Boehringer Ingelheim Investigational Site
New Haven, Connecticut
248.595.0129 Boehringer Ingelheim Investigational Site
New York, New York
248.595.0124 Boehringer Ingelheim Investigational Site
Palm Beach Gardens, Florida
248.595.0123 Boehringer Ingelheim Investigational Site
Panama City, Florida
248.595.0139 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
248.595.0131 Boehringer Ingelheim Investigational Site
Scarbourough, Maine
248.595.0104 Boehringer Ingelheim Investigational Site
Scottsdale, Arizona
248.595.0109 Boehringer Ingelheim Investigational Site
South Miami, Florida
248.595.0115 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
248.595.0106 Boehringer Ingelheim Investigational Site
Tampa, Florida
248.595.0102 Boehringer Ingelheim Investigational Site
Traverse City, Michigan
248.595.0118 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
248.595.0114 Boehringer Ingelheim Investigational Site
Warwick, Rhode Island
248.595.0136 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
248.595.0141 Boehringer Ingelheim Investigational Site
Worcester, Massachusetts
Germany13 sites
248.595.49006 Boehringer Ingelheim Investigational Site
Augsburg
248.595.49008 Boehringer Ingelheim Investigational Site
Berlin
248.595.49007 Boehringer Ingelheim Investigational Site
Bochum
248.595.49011 Boehringer Ingelheim Investigational Site
Bonn
248.595.49016 Boehringer Ingelheim Investigational Site
Gera
248.595.49009 Boehringer Ingelheim Investigational Site
Göttingen
248.595.49004 Boehringer Ingelheim Investigational Site
Hamburg
248.595.49010 Boehringer Ingelheim Investigational Site
Hanau
248.595.49005 Boehringer Ingelheim Investigational Site
Hanover
248.595.49012 Boehringer Ingelheim Investigational Site
Leipzig
248.595.49001 Boehringer Ingelheim Investigational Site
Marburg
248.595.49015 Boehringer Ingelheim Investigational Site
München
248.595.49014 Boehringer Ingelheim Investigational Site
Tübingen
Italy13 sites
248.595.39004 Università degli Studi di Bari
Bari
248.595.39009 Ospedale di Bellaria
Bologna
248.595.39005 Ospedale della Misericordia
Grosseto
248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento
Milan
248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena
Milan
248.595.39011 Ospedale S. Raffaele - IRCCS
Milan
248.595.39002 Università Federico II
Naples
248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
Pisa
248.595.39014 Boehringer Ingelheim Investigational Site
Roma
248.595.39006 Policlinico Universitario Molinette
Torino
248.595.39007 Ospedale Evangelico Valdese
Torino
248.595.39013 Ospedale Umberto I
Venezia Mestre
248.595.39003 Ospedale di Viareggio
Viareggio
France12 sites
248.595.3306A Centre Hospitalier du Pays d'Aix
Aix-en-Provence
248.595.3306B Centre Hospitalier du Pays d'Aix
Aix-en-Provence
248.595.3306C Centre Hospitalier du Pays d'Aix
Aix-en-Provence
248.595.3301A Hôpital Gabriel Montpied
Clermont-Ferrand
248.595.3301B Hôpital Gabriel Montpied
Clermont-Ferrand
248.595.3303A Cabinet Médical
Évreux
248.595.3307A Hôpital Roger Salengro
Lille
248.595.3307B Hôpital Roger Salengro
Lille
248.595.3302A Hôpital La Timone
Marseille
248.595.3302B Hôpital La Timone
Marseille
248.595.3305A Hôpital Purpan
Toulouse
248.595.3305C Hôpital Purpan
Toulouse
United Kingdom8 sites
248.595.44003 Boehringer Ingelheim Investigational Site
Birmingham
248.595.44008 Boehringer Ingelheim Investigational Site
Glasgow
248.595.44004 Boehringer Ingelheim Investigational Site
London
248.595.44002 Boehringer Ingelheim Investigational Site
Newark
248.595.44001 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne
248.595.44010 Boehringer Ingelheim Investigational Site
North Shields
248.595.44011 Boehringer Ingelheim Investigational Site
Romford
248.595.44005 Boehringer Ingelheim Investigational Site
Stoke-on-Trent
Sweden6 sites
248.595.46004 Boehringer Ingelheim Investigational Site
Jönköping
248.595.46006 Boehringer Ingelheim Investigational Site
Linköping
248.595.46005 Boehringer Ingelheim Investigational Site
Norrköping
248.595.46002 Boehringer Ingelheim Investigational Site
Örebro
248.595.46001 Boehringer Ingelheim Investigational Site
Stockholm
248.595.46007 Boehringer Ingelheim Investigational Site
Stockholm
Austria5 sites
248.595.43005 Boehringer Ingelheim Investigational Site
Bruck A. D. Mur
248.595.43003 Boehringer Ingelheim Investigational Site
Graz
248.595.43001 Boehringer Ingelheim Investigational Site
Innsbruck
248.595.43002 Boehringer Ingelheim Investigational Site
Vienna
248.595.43004 Boehringer Ingelheim Investigational Site
Vienna
Spain5 sites
248.595.34003 Hospital de Alcorcon
Alcorcon (Madrid)
248.595.34001 Hospital Clinic i Provincial of Barcelona
Barcelona
248.595.34002 Nuevo Hospital de Sant Pau
Barcelona
248.595.34004 Hospital 12 de Octubre
Madrid
248.595.34005 Hospital Mutua de Terrassa
Tarrasa (Barcelona)
Finland3 sites
248.595.35803 Boehringer Ingelheim Investigational Site
Helsinki
248.595.35804 Boehringer Ingelheim Investigational Site
Lahti
248.595.35801 Boehringer Ingelheim Investigational Site
Oulu
Japan2 sites
248.595.81001 Juntendo University Hospital
Bunkyo-ku, Tokyo
248.595.81002 Kagawa Prefectural Central Hospital
Takamatsu, Kagawa
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.
This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease
- Conditions
- Parkinson Disease
- Being tested
- pramipexole
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pramipexoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Early Pramipexole | Experimental | Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day). Receives: Drug: pramipexole |
| Delayed Pramipexole | Experimental | Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day). Receives: Drug: pramipexole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Measured: Baseline and Month 15
Secondary outcomes (56)
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Measured: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Measured: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Measured: Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Measured: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Measured: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Measured: Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Measured: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Measured: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Measured: Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Measured: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Measured: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Measured: Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Measured: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Measured: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Measured: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Measured: Baseline and Month 3
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.
Measured: Month 15
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).
Measured: Baseline and Month 15
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Measured: Baseline and Month 15
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Measured: Baseline and Month 9
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Measured: Baseline and Month 6
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Measured: Baseline and Month 3
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Measured: Baseline and Month 15
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Measured: Baseline and Month 9
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Measured: Baseline and Month 15
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Measured: Baseline and Month 9
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Measured: Baseline and Month 15
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Measured: Baseline and Month 9
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Measured: Month 1
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Measured: Month 6
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Measured: Month 9
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Measured: Month 12
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Measured: Month 15
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Measured: Month 1
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Measured: Month 6
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Measured: Month 9
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Measured: Month 12
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Measured: Month 15
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Measured: Month 1
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Measured: Month 6
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Measured: Month 9
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Measured: Month 12
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Measured: Month 15
Percentage Change From Baseline in the Striatum Uptake at Month 15
The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).
Measured: Baseline and Month 15
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Measured: Baseline and Month 15
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Measured: Baseline and Month 15
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Measured: Baseline and Month 15
Clinically Significant Abnormalities in Vital Signs
Measured: Baseline and Month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321854
- Sponsor's protocol ID
- 248.595
- Status last verified
- Mar 2014
- First submitted
- 3 May 2006
- Last updated
- 16 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Schapira AH, McDermott MP, Barone P, Comella CL, Albrecht S, Hsu HH, Massey DH, Mizuno Y, Poewe W, Rascol O, Marek K. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial. Lancet Neurol. 2013 Aug;12(8):747-55. doi: 10.1016/S1474-4422(13)70117-0. Epub 2013 May 31.
PubMed 23726851
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT00321854
- Acronym / sponsor ID
- 248.595
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2009 (actual)
- First posted
- 4 May 2006 (estimated)
- Results
- Posted 26 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Pramipexole | Experimental | Drug: pramipexolePatients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day). |
| Delayed Pramipexole | Experimental | Drug: pramipexolePatients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day). |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
- Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
- Parkinsons disease newly diagnosed within the past 2 years;
- Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);
- Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (19 listed)
- Previous history of allergic response or complications with pramipexole (PPX) or its excipients;
- Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
- The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
- The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;
- If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pramipexole | Drug | Delayed Pramipexole, Early Pramipexole |
Primary outcome
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
Time frame: Baseline and Month 15
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
56 secondary outcomes
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
Time frame: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
Time frame: Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
Time frame: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
Time frame: Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
Time frame: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
Time frame: Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
Time frame: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
Time frame: Baseline and Month 3
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
Time frame: Baseline and Month 9
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
Time frame: Baseline and Month 3
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
Time frame: Month 15
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
Time frame: Baseline and Month 9
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
Time frame: Baseline and Month 3
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
Time frame: Baseline and Month 9
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
Time frame: Baseline and Month 9
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
Time frame: Baseline and Month 15
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
Time frame: Baseline and Month 9
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
Time frame: Month 1
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
Time frame: Month 6
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
Time frame: Month 9
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23726851Schapira AH, McDermott MP, Barone P, Comella CL, Albrecht S, Hsu HH, Massey DH, Mizuno Y, Poewe W, Rascol O, Marek K. Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial. Lancet Neurol. 2013 Aug;12(8):747-55. doi: 10.1016/S1474-4422(13)70117-0. Epub 2013 May 31.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
99 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim at 99 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 99 sites in United States, Germany, Italy, France, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 (time frame: Baseline and Month 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00321854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.