Brief 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. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.

Trial Health

On Track

Trial Health Score

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

Enrollment

564

participants targeted

Target at P75+ for phase_2 parkinson-disease

Timeline

Completed

Started Jul 2003

Typical duration for phase_2 parkinson-disease

Geographic Reach

13 countries

13 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

July 1, 2003

Completed

2.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed

Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

2.8 years

First QC Date

September 26, 2005

Last Update Submit

December 22, 2008

Conditions

Parkinson Disease

Keywords

Parkinson Diseaselevodopadopamine agonists

Outcome Measures

Primary Outcomes (1)

Time to disability warranting introduction of Ldopaor a dopamine agonist.

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.
Untreated patients.
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 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.
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.