NCT00220272|CompletedPhase 2

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

Sanofi ClinicalTrials.gov

Compare

1 other identifier

ACT5288

Study Type

interventional

Target

183

Locations

7 countries

Sites

Timeline

RegisteredSep 2005

StartedJan 2004

CompletionMar 2007

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

183

participants targeted

Target at P75+ for phase_2 parkinson-disease

Timeline

Completed

Started Jan 2004

Typical duration for phase_2 parkinson-disease

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

January 1, 2004

Completed

1.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed

Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

3.2 years

First QC Date

September 16, 2005

Last Update Submit

December 22, 2008

Conditions

Parkinson Disease

Keywords

Parkinson Disease5-fluorodopa

Outcome Measures

Primary Outcomes (1)

Change in average (left and right) putamen 18F-Dopa influx constant (Ki) from baseline to two year 18F-Dopa PET

Secondary Outcomes (1)

Unified Parkinson's Disease Rating Scale (UPDRS)

Interventions

SR57667BDRUG

Eligibility Criteria

Age35 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.