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SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

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ClinicalTrials.gov Identifier: NCT00335166
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : April 3, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Condition or disease Intervention/treatment Phase
Early Stage Parkinson Disease Drug: Pardaprunox Drug: pramipexole Drug: Placebo Comparator Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Pardaprunox
12-42 mg
Active Comparator: 2 Drug: pramipexole
1.5-4.5 mg
Placebo Comparator: 3 Drug: Placebo Comparator
Placebo



Primary Outcome Measures :
  1. UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment. [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335166


  Show 89 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ellen van Kleef, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00335166     History of Changes
Other Study ID Numbers: S308.3.003
Not requested yet
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: April 2008

Keywords provided by Solvay Pharmaceuticals:
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents