Parkinson DiseasePhase 4NCT00297778
Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
A Phase 4 study testing Pramipexole in people with Parkinson Disease and Depression, run by Boehringer Ingelheim at 77 sites in 13 countries.
Trial summary
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease, Depression
- What is being tested?
- Pramipexole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 77 sitesin 13 countries
- Study dates
- Mar 2006to May 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 15-item Geriatric Depression Scale (GDS) > or = 5
- Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score on Question #3 > or = 2
- Folsteins Mini-Mental State Examination (MMSE) score > 24
- Male or female patient with PD (UK PD Brain Bank criteria).
- Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr Scale and optimally controlled PD symptoms .
- Male or female patients aged 30 - 80 years.
Show all 10Show fewer
- Ability to provide written informed consent.
- Women of childbearing potential must have a negative serum beta-humanchoriongonadotropin (Beta-HCG) pregnancy test at the Screening visit unless surgically sterile or last menstruation >or = 12 months prior to signing informed consent.
- Women of childbearing potential must be using an accepted contraceptive.
- 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, lack of efficacy or complications with pramipexole or its excipients.
- History of suicidal attempts in the last twelve months; presence of suicidal tendencies/potential.
- Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- History of PD stereotactic brain surgery.
- Surgery within 180 days of randomization that would negatively impact the patients participation in the study.
- History of active epilepsy within the past year.
Show all 16Show fewer
- Current psychotherapy or behavior therapy while participating the trial
- Symptomatic orthostatic hypotension prior to randomization.
- Malignant melanoma or history of previously treated malignant melanoma.
- Patients who have received typical neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, selegiline or amphetamine derivatives within the past 3 months.
- Patients who have received dopamine agonists within the past 30 days
- Electroconvulsive therapy during the 90 days preceding the screening visit (Visit 1).
- Patients who are currently lactating.
- Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization.
- Any other laboratory assay abnormality, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
- Any other clinically significant medical/psychiatric condition, which could interfere with patient participation or interpretation of results, or could increase the risk for the patient
Trial locations and contacts
77 sites in 13 countries.
77 sites in 13 countries
France12 sites
248.596.3302A Centre Hospitalier du Pays d'Aix
Aix-en-Provence
248.596.3302B Centre Hospitalier du Pays d'Aix
Aix-en-Provence
248.596.3306A Hôpital Pierre Wertheimer
Bron
248.596.3308A Hôpital Gabriel Montpied
Clermont-Ferrand
248.596.3309A Cabinet Médical
Évreux
248.596.3307A Hôpital Roger Salengro
Lille
248.596.3307B Hôpital Roger Salengro
Lille
248.596.3307C Hôpital Roger Salengro
Lille
248.596.3303A Hôpital La Timone
Marseille
248.596.3305A Hôpital du Haut Levêque
Pessac Cédex
248.596.3305B Hôpital du Haut Levêque
Pessac Cédex
248.596.3301A Hôpital Guillaume et René Laennec
Saint-Herblain
Germany11 sites
248.596.49002 Boehringer Ingelheim Investigational Site
Berlin
248.596.49013 Boehringer Ingelheim Investigational Site
Berlin
248.596.49015 Boehringer Ingelheim Investigational Site
Berlin
248.596.49003 Boehringer Ingelheim Investigational Site
Bremerhaven
248.596.49016 Boehringer Ingelheim Investigational Site
Cologne
248.596.49004 Boehringer Ingelheim Investigational Site
Gera
248.596.49001 Boehringer Ingelheim Investigational Site
Karlsruhe
248.596.49005 Boehringer Ingelheim Investigational Site
Marburg
248.596.49014 Boehringer Ingelheim Investigational Site
Mittweida
248.596.49008 Boehringer Ingelheim Investigational Site
München
248.596.49012 Boehringer Ingelheim Investigational Site
Steglitz
Italy8 sites
248.596.39008 Clinica Neurologica I Policlinico di Catania
Catania
248.596.39004 Neurologia Ospedale della Misericordia
Grosseto
248.596.39005 Clinica Neurologica Policlinico G. Martino
Messina
248.596.39009 Istituti Clinici di Perfezionamento
Milan
248.596.39003 Università degli studi di Napoli "Federico II"
Naples
248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"
Pescara
248.596.39007 Clinica Neurologica Policlinico Tor Vergata
Roma
248.596.39006 Neurologia Ospedale Evangelico Valdese
Torino
Netherlands6 sites
248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA
's-Hertogenbosch
248.596.31007 Afdeling neurologie
Amsterdam
248.596.31005 Ziekenhuis Gooi-Noord
Blaricum
248.596.31004 Amphia ziekenhuis, Locatie Molengracht
Breda
248.596.31002 Canisius-Wilhelmina Ziekenhuis
Nijmegen
248.596.31001 Maasland Ziekenhuis
Sittard
Romania6 sites
248.596.40003 Boehringer Ingelheim Investigational Site
Bucharest
248.596.40004 Boehringer Ingelheim Investigational Site
Bucharest
248.596.40005 Boehringer Ingelheim Investigational Site
Bucharest
248.596.40001 Boehringer Ingelheim Investigational Site
Cluj-Napoca
248.596.40002 Boehringer Ingelheim Investigational Site
Iași
248.596.40006 Country Clinical Emergency Hospital
Târgu Mureş
South Africa6 sites
248.596.27001 Boehringer Ingelheim Investigational Site
Cape Town
248.596.27003 Boehringer Ingelheim Investigational Site
Cape Town
248.596.27007 Boehringer Ingelheim Investigational Site
Cape Town
248.596.27008 Boehringer Ingelheim Investigational Site
Johannesburg
248.596.27004 Boehringer Ingelheim Investigational Site
Pretoria
248.596.27006 Boehringer Ingelheim Investigational Site
Richards Bay
Spain6 sites
248.596.34003 Hospital de Alcorcón. Departamento de Neurología
Alcorcon (Madrid)
248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología
Barcelona
248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología
Barcelona
248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología
Barcelona
248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología
Madrid
248.596.34004 Hospital General de Catalunya. Departamento de Neurología
San Cugat Del Valles (Barcelona)
Austria5 sites
248.596.43003 Boehringer Ingelheim Investigational Site
Graz
248.596.43001 Boehringer Ingelheim Investigational Site
Innsbruck
248.596.43005 Boehringer Ingelheim Investigational Site
Linz
248.596.43004 Boehringer Ingelheim Investigational Site
Sankt Pölten
248.596.43002 Boehringer Ingelheim Investigational Site
Vienna
Russia5 sites
248.596.70001 Boehringer Ingelheim Investigational Site
Moscow
248.596.70003 Boehringer Ingelheim Investigational Site
Moscow
248.596.70002 Boehringer Ingelheim Investigational Site
Saint Petersburg
248.596.70004 Boehringer Ingelheim Investigational Site
Saint Petersburg
248.596.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg
Ukraine5 sites
248.596.38004 Boehringer Ingelheim Investigational Site
Donetsk
248.596.38005 Boehringer Ingelheim Investigational Site
Kharkiv
248.596.38002 Boehringer Ingelheim Investigational Site
Kiev
248.596.38006 Boehringer Ingelheim Investigational Site
Simferopol
248.596.38003 Boehringer Ingelheim Investigational Site
Vinnytzya
Norway3 sites
248.596.47002 Boehringer Ingelheim Investigational Site
Arendal
248.596.47004 Boehringer Ingelheim Investigational Site
Lillehammer
248.596.47003 Boehringer Ingelheim Investigational Site
Sandvika
Sweden3 sites
248.596.46004 Boehringer Ingelheim Investigational Site
Linköping
248.596.46001 Boehringer Ingelheim Investigational Site
Stockholm
248.596.46002 Boehringer Ingelheim Investigational Site
Stockholm
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance.
However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression.
Read more
The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients.
Also data on the safety of the product in the disease will be collected.
- Conditions
- Parkinson Disease, Depression
- Being tested
- Pramipexole, Placebo
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
Dopamine agonist
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| pramipexole | Experimental | A daily dose of pramipexole 0.125 mg t.i.d.; titration-to-response up to 1.0 mg t.i.d. Receives: Drug: Pramipexole |
| placebo | Placebo comparator | Placebo (matching) tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Measured: Baseline and Week 12
Secondary outcomes (14)
Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
BDI clinical response was defined as a reduction of ≥50% from baseline
Measured: Week 12
Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)
Measured: Baseline and Week 12
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)
Measured: Baseline and Week 12
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)
Measured: Baseline and Week 12
Change From Baseline in the UPDRS Part II Total Score at Week 12
Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)
Measured: Baseline and Week 12
Change From Baseline in the UPDRS Part III Total Score at Week 12
The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)
Measured: Baseline and Week 12
Change From Baseline in the UPDRS Part II+III Total Score at Week 12
The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)
Measured: Baseline and Week 12
Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
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)
Measured: Week 12
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
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 Week 12
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Measured: Baseline and Week 12
Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12
The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 - 10 cm) line representing the patient's degree of general pain. The two extremities of the line were taken to represent 'no pain' and 'unbearable pain', respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).
Measured: Baseline and Week 12
Change From Baseline in the UPDRS Part I Total Score at Week 12
The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.
Measured: Baseline and Week 12
Change From Baseline in the UPDRS Part IV Total Score at Week 12
The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.
Measured: Baseline and Week 12
Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2008
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
- 296 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
- NCT00297778
- Sponsor's protocol ID
- 248.596
- Other IDs
- Eudract 2005-003788-22
- Status last verified
- Apr 2014
- First submitted
- 28 Feb 2006
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Barone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. doi: 10.1016/S1474-4422(10)70106-X. Epub 2010 May 7.
PubMed 20452823
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms
- ClinicalTrials.gov ID
- NCT00297778
- Acronym / sponsor ID
- 248.596
- Conditions
- Parkinson Disease, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Posted 24 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance.
However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression.
The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients.
Also data on the safety of the product in the disease will be collected.
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 |
|---|---|---|
| pramipexole | Experimental | Drug: PramipexoleA daily dose of pramipexole 0.125 mg t.i.d.; titration-to-response up to 1.0 mg t.i.d. |
| placebo | Placebo comparator | Other: PlaceboPlacebo (matching) tablets |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 15-item Geriatric Depression Scale (GDS) > or = 5
- Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score on Question #3 > or = 2
- Folsteins Mini-Mental State Examination (MMSE) score > 24
- Male or female patient with PD (UK PD Brain Bank criteria).
- Patients diagnosed with idiopathic PD, Stage I-III by the Modified Hoehn and Yahr Scale and optimally controlled PD symptoms .
Key exclusion criteria (16 listed)
- Previous history of allergic response, lack of efficacy or complications with pramipexole or its excipients.
- History of suicidal attempts in the last twelve months; presence of suicidal tendencies/potential.
- Atypical PD syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- History of PD stereotactic brain surgery.
- Surgery within 180 days of randomization that would negatively impact the patients participation in the study.
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 |
|---|---|---|
| PramipexoleDopamine agonist | Drug | pramipexole |
| Placebo | Other | placebo |
Primary outcome
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12
Time frame: Baseline and Week 12
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
14 secondary outcomes
Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12
Time frame: Week 12
Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the UPDRS Part II Total Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the UPDRS Part III Total Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the UPDRS Part II+III Total Score at Week 12
Time frame: Baseline and Week 12
Clinical Global Impressions of Global Improvement (CGI-I) at Week 12
Time frame: Week 12
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the UPDRS Part I Total Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the UPDRS Part IV Total Score at Week 12
Time frame: Baseline and Week 12
Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20452823Barone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. doi: 10.1016/S1474-4422(10)70106-X. Epub 2010 May 7.
- Related InfoLink provided by the sponsor.
- 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
77 sites in 13 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 and Depression, run by Boehringer Ingelheim at 77 sites in 13 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 10 inclusion and 16 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in France, Germany, Italy, Netherlands, Romania and 8 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. Some participants in this study may receive a placebo. 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 24 Sep 2009). 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 Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 (time frame: Baseline and Week 12). 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 NCT00297778, 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 9 Jun 2014.