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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00335166 |
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Date of registration:
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08/06/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
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Scientific title:
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A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease. |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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330 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00335166 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Czech Republic
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Estonia
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France
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Germany
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India
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Italy
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Lithuania
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Malaysia
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Netherlands
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Poland
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Portugal
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South Africa
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Spain
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Taiwan
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Thailand
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United Kingdom
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United States
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Contacts
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Name:
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Global Clinical Director Solvay |
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Address:
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Telephone:
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Email:
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Affiliation:
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Solvay Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn & Yahr up to stage III,
UPDRS motor score (part III) must have a total of at least 10 at baseline.
Exclusion Criteria:
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
- Patients who have undergone surgery for the treatment of PD,
- Current presence of dyskinesias,
- Motor fluctuations or loss of postural reflexes,
- A history of non-response to an adequate course of l-dopa or a dopamine agonist,
- Patients for whom previously treatment with dopamine agonists needed to terminate
because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Early Stage Parkinson Disease
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Intervention(s)
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Drug: Placebo Comparator
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Drug: Pardaprunox
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Drug: pramipexole
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Primary Outcome(s)
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UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.
[Time Frame: 24 weeks]
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Secondary ID(s)
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Not requested yet
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S308.3.003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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