Parkinson DiseasePhase 2NCT00148512
A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations
A Phase 2 study testing 1. Tesofensine (NS 2330) in people with Parkinson Disease, run by Boehringer Ingelheim at 50 sites in 6 countries.
Trial summary
The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations. Read more about this study
- Who is it for?
- Ages 42 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 1. Tesofensine (NS 2330)
- How many people
- 254 participants
- Where
- 50 sitesin 6 countries
- Study dates
- Mar 2003to Feb 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 42 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion criteria:
- Male or female patient with idiopathic Parkinson Disease (PD) diagnosed for at least 2 years.
- Patient aged 40 years or over at time of diagnosis of PD and not older than 80 years at screening visit.
- Modified Hoehn and Yahr stage of II to III at "on" time.
- Treatment with Levodopa at an optimised dose, 4 to 8 times per day, this dose being stable for at least 4 weeks prior to screening visit.
- Motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit.
Main exclusion criteria:
- Neuropsychiatric exclusions: Non-idiopathic PD, dementia (Mini Mental State Exam <26), history of psychosis, history or current Axis I or Axis II mental disorder according to DSM-IV, etc
- Other medical exclusions, like ECG abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc
- Pharmacological exclusions, e.g. selegiline within 8 weeks prior to screening visit, regular use of anti-depressant drugs, any medication with central dopaminergic antagonist activity, etc
Trial locations and contacts
50 sites in 6 countries.
50 sites in 6 countries
Germany16 sites
Universitätsklinikum der Humboldt-Universität
Berlin, 10117
Boehringer Ingelheim Investigational Site
Berlin, 10178
Boehringer Ingelheim Investigational Site
Berlin, 12163
Boehringer Ingelheim Investigational Site
Berlin, 12167
Boehringer Ingelheim Investigational Site
Berlin, 13507
St. Josef-Hospital
Bochum, 44791
Boehringer Ingelheim Investigational Site
Gera, 07551
Boehringer Ingelheim Investigational Site
Herborn, 35745
Paracelsus-Elena-Klinik
Kassel, 34128
Christian Albrechts Universität zu Kiel
Kiel, 24105
Universität Leipzig
Leipzig, 04103
Klinik für Neurologie
Marburg, 35033
Klinikum Großhadern der L.M.-Universität
München, 81377
Universitätsklinik Rostock
Rostock, 18147
Universitätsklinikum Ulm
Ulm, 89075
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, 65191
France10 sites
Hôpital du Pays d'Aix
Aix-en-Provence, 13616
Hôpital Pierre Wertheimer
Bron, 69677
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Hôpital Roger Salengro
Lille, 59037
Hôpital de la Timone
Marseille, 13385
Service de Neurologie
Paris, 75013
Hôpital du Haut-Levèque
Pessac, 33604
Centre Hospitalier Universitaire JB Miletrie
Poitiers, 86021
Hôpital Guillaume et René Laennec
Saint-Herblain, 44800
Hôpital Purpan
Toulouse, 31073
United Kingdom7 sites
City Hospital
Birmingham, B18 7QH
Neurology Department
Blackburn, BB2 3L0
Neurology Department
Glasgow, G51 4TF
Walton Centre for Neurology
Liverpool, L9 7LJ
Regional Neurosciences Centre
Newcastle upon Tyne, NE4 6BE
Neurology Research
Stoke-on-Trent, ST4 7LN
Neurology Department
Swansea, 6AS 6NL
Austria6 sites
Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg
Graz, 8020
Univ.-Klinik für Neurologie
Graz, 8036
Univ.-Klinik für Neurologie
Innsbruck, 6020
Landesnervenklinik Wagner Jauregg Linz
Linz, 4020
AKH der Stadt Linz
Linz, 4021
Landesklinikum St. Pölten
Sankt Pölten, 3100
Spain6 sites
Hospital Vall d'Hebrón
Barcelona, 08035
Hospital Clinic i Provincial de BCN
Barcelona, 08036
Hospital de la Sta. Creu i Sant Pau
Barcelona, 08041
Hospital Gregorio Marañón
Madrid, 28007
Hospital Clínico niversitario de Santiago de Compostela
Santiago de Compostela, 15706
Hospital Clínico Universitario Vírgen de la Macarena
Seville, 41071
Netherlands5 sites
Locatie Willem-Alexander
's-Hertogenbosch, 5223 GV
Boehringer Ingelheim Investigational Site
Breda, 4818 CK
Martini ziekenhuis
Groningen, 9728 RM
Maasland Ziekenhuis
Sittard, 6163 BK
Boehringer Ingelheim Investigational Site
Utrecht, 3584 CX
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)
The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, five parallel groups efficacy and safety exploratory of tesofensine versus placebo in levodopa treated Parkinson patients with motor fluctuations.
Patients will be treated either with one of the 4 doses of tesofensine (0.125mg, 0.25mg, 0.50 mg or 1.0 mg) or with placebo, once daily, over 14 weeks.
The two co-primary efficacy endpoints are the change in off-time and the change in the Unified Parkinson Disease Rating Scale (UPDRS) II+III total score
Study Hypothesis:
The null hypothesis is that there is no difference between placebo and tesofensine.
The alternative hypothesis is that treatment with tesofensine is superior to treatment with placebo.
Comparison(s):
For the primary comparison between tesofensine and placebo, change in percentage off-time during waking hours will be based on reports from patient's diary (completed at day -3 and day-2 prior to the study visits) and change in the UPDRS II+III will be based on UPDRS II averaged for on and off periods and UPDRS III evaluated at on periods during the study visits.
- Conditions
- Parkinson Disease
- Being tested
- 1. Tesofensine (NS 2330)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Tesofensine (NS 2330)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS parts II (averaged "on" and "off")
Measured: 14 weeks
"Off" time during waking hours
Measured: 14 weeks
Secondary outcomes (8)
Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia
Measured: 14 weeks
Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores
Measured: 14 weeks
Clinical Global Impressions (CGI) Improvement and Severity
Measured: 14 weeks
Auditory Verbal Learning test (AVLT)
Measured: 14 weeks
Modified Schwab and England Disability scale
Measured: 14 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
Measured: 14 weeks
Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours
Measured: 14 weeks
Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, BI France S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148512
- Sponsor's protocol ID
- 1198.101
- Status last verified
- Oct 2013
- First submitted
- 7 Sep 2005
- Last updated
- 29 Oct 2013
- Results posted
- No
Publications
Rascol O, Poewe W, Lees A, Aristin M, Salin L, Juhel N, Waldhauser L, Schindler T; ADVANS Study Group. Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study. Arch Neurol. 2008 May;65(5):577-83. doi: 10.1001/archneur.65.5.577.
PubMed 18474731
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)
- ClinicalTrials.gov ID
- NCT00148512
- Acronym / sponsor ID
- 1198.101
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.
Detailed description
This is a randomized, double-blind, placebo-controlled, five parallel groups efficacy and safety exploratory of tesofensine versus placebo in levodopa treated Parkinson patients with motor fluctuations.
Patients will be treated either with one of the 4 doses of tesofensine (0.125mg, 0.25mg, 0.50 mg or 1.0 mg) or with placebo, once daily, over 14 weeks.
The two co-primary efficacy endpoints are the change in off-time and the change in the Unified Parkinson Disease Rating Scale (UPDRS) II+III total score
Study Hypothesis:
The null hypothesis is that there is no difference between placebo and tesofensine.
The alternative hypothesis is that treatment with tesofensine is superior to treatment with placebo.
Comparison(s):
For the primary comparison between tesofensine and placebo, change in percentage off-time during waking hours will be based on reports from patient's diary (completed at day -3 and day-2 prior to the study visits) and change in the UPDRS II+III will be based on UPDRS II averaged for on and off periods and UPDRS III evaluated at on periods during the study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 42 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 1. Tesofensine (NS 2330) | Drug | – |
Primary outcome
UPDRS parts II (averaged "on" and "off")
Time frame: 14 weeks
"Off" time during waking hours
Time frame: 14 weeks
8 secondary outcomes
Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia
Time frame: 14 weeks
Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores
Time frame: 14 weeks
Clinical Global Impressions (CGI) Improvement and Severity
Time frame: 14 weeks
Auditory Verbal Learning test (AVLT)
Time frame: 14 weeks
Modified Schwab and England Disability scale
Time frame: 14 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: 14 weeks
Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours
Time frame: 14 weeks
Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Derived from this study: PubMed 18474731Rascol O, Poewe W, Lees A, Aristin M, Salin L, Juhel N, Waldhauser L, Schindler T; ADVANS Study Group. Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study. Arch Neurol. 2008 May;65(5):577-83. doi: 10.1001/archneur.65.5.577.
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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 Coordinator study chair
BI France S.A.S.
50 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1. Tesofensine (NS 2330) in people with Parkinson Disease, run by Boehringer Ingelheim at 50 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Germany, France, United Kingdom, Austria, Spain and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
UPDRS parts II (averaged "on" and "off") (time frame: 14 weeks). The study lists 2 primary outcomes in all. 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 NCT00148512, 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 29 Oct 2013.