Parkinson DiseasePhase 2NCT00228150
Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease
A Phase 2 study testing SR57667B in people with Parkinson Disease, run by Sanofi at 13 sites in 13 countries.
Trial summary
The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression of disability warranting initiation of L-dopa or a dopamine agonist. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- SR57667B
- How many people
- 564 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Jul 2003to Apr 2006
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients.
- Age >=35 years at screening.·
- Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
- Duration of the disease of less than 3 years since diagnosis·
- Modified Hoehn and Yahr stage <= 2.5.
- Untreated patients.
- Generally healthy and ambulatory.
- Patient has given his informed written consent and is capable of following study procedures.
Who cannot join
- Any indication of forms of parkinsonism other than PD.
- Severe resting tremor.
- Presence of either dyskinesia, fluctuations, or loss of postural reflexes·
- Treatment with L-Dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa.
- Electroconvulsive therapy (ECT).
- Use of CYP3A4 strong, and moderate inducers or inhibitors.
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- Participation in another clinical trial with an investigational drug within two months prior to randomization.
- Dementia, uncontrolled depression, psychotic disorder.
- History of substance-related disorders including alcohol or other substance use disorders.
- Females of child bearing potential.
- Evidence (detected by history, physical examination and/or laboratory/ECG tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug.
- Alterations of laboratory tests or ECG findings of potential clinical significance.
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guilford Surrey
About this study
Official title: A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease
The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression of disability warranting initiation of L-dopa or a dopamine agonist. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.
Read the detailed description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.
- Conditions
- Parkinson Disease
- Being tested
- SR57667B
- Keywords
- Parkinson Disease, levodopa, dopamine agonists
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR57667BDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disability warranting introduction of Ldopaor a dopamine agonist.
Secondary outcomes (1)
Unified Parkinson's Disease Rating Scale (UPDRS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark GUTMAN, MD, Study chair, Scientific Advisory CommitteeWerner POEWE, MD, Study chair, Scientific Advisory CommitteeOlivier RASCOL, MD, Study chair, Scientific Advisory CommitteeEduardo TOLOSA, MD, Study chair, Scientific Advisory Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228150
- Sponsor's protocol ID
- EFC5287
- Status last verified
- Dec 2008
- First submitted
- 26 Sep 2005
- Last updated
- 23 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00228150
- Acronym / sponsor ID
- EFC5287
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, levodopa, dopamine agonists
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 28 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 is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression of disability warranting initiation of L-dopa or a dopamine agonist. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.
Detailed description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female outpatients.
- Age >=35 years at screening.·
- Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
- Duration of the disease of less than 3 years since diagnosis·
- Modified Hoehn and Yahr stage <= 2.5.
Key exclusion criteria (12 listed)
- Any indication of forms of parkinsonism other than PD.
- Severe resting tremor.
- Presence of either dyskinesia, fluctuations, or loss of postural reflexes·
- Treatment with L-Dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa.
- Electroconvulsive therapy (ECT).
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 |
|---|---|---|
| SR57667B | Drug | – |
Primary outcome
Time to disability warranting introduction of Ldopaor a dopamine agonist.
1 secondary outcome
Unified Parkinson's Disease Rating Scale (UPDRS)
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 23 Dec 2008.
- 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.
Mark GUTMAN, MD study chair
Scientific Advisory Committee
Werner POEWE, MD study chair
Scientific Advisory Committee
Olivier RASCOL, MD study chair
Scientific Advisory Committee
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR57667B in people with Parkinson Disease, run by Sanofi at 13 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 8 inclusion and 12 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 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Austria, Canada, Denmark, France, Germany 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. 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?
Time to disability warranting introduction of Ldopaor a dopamine agonist.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2008.