Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00220272
First received: September 16, 2005
Last updated: December 22, 2008
Last verified: December 2008

September 16, 2005
December 22, 2008
January 2004
March 2007   (final data collection date for primary outcome measure)
Change in average (left and right) putamen 18F-Dopa influx constant (Ki) from baseline to two year 18F-Dopa PET
Same as current
Complete list of historical versions of study NCT00220272 on ClinicalTrials.gov Archive Site
Unified Parkinson's Disease Rating Scale (UPDRS)
Unified Parkinson’s Disease Rating Scale (UPDRS)
Not Provided
Not Provided
 
Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's Disease
A Phase II, Randomized, Multicenter, Multinational, Double-Blind, Placebo-Controlled, Study of the Effect of SR57667B on Dopaminergic Nigro-Striatal Function Assessed by 18F-Dopa PET Imaging in Outpatients With Early Parkinson's Disease
  • The primary objective is to study the effect of SR57667B at the dose of 4 mg/d on progression of dopaminergic nigro-striatal lesions assessed by 18F-Dopa PET imaging.
  • Secondary objectives are to assess the effect of SR57667B on symptomatic decline in patients with early PD, to assess the safety/tolerability of SR57667B in patients with early PD and to document plasma concentrations of SR57667 in patients with early PD.

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.Randomization stratified on the dopaminergic treatment, in two strata: treatment by levodopa or dopamine agonist.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson Disease
Drug: SR57667B
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • Patient optimized on monotherapy by levodopa or a dopamine agonist·
  • Generally healthy and ambulatory.
  • Patient has given his informed written consent and is capable of following study procedures.

Exclusion Criteria:

  • Any indication of forms of parkinsonism other than PD.
  • Severe resting tremor. Presence of either dyskinesia, fluctuations, or loss of postural reflexes·
  • Treatment with 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. 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.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Finland,   France,   Netherlands,   Spain,   Switzerland,   United Kingdom
 
NCT00220272
ACT5288
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Chair: Philippe Remy, MD Service Hospitalier Frédéric Joliot, CEA, Orsay France
Sanofi
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP