SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease - Full Text View

Purpose

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	Intervention	Phase
Early Stage Parkinson Disease	Drug: Pardaprunox Drug: pramipexole Drug: Placebo Comparator	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Pramipexole dihydrochloride Pramipexole

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	November 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Pardaprunox 12-42 mg
Active Comparator: 2	Drug: pramipexole 1.5-4.5 mg
Placebo Comparator: 3	Drug: Placebo Comparator Placebo

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335166

Show 89 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided by Solvay Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. Epub 2011 May 3.

Responsible Party:	Ellen van Kleef, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00335166 History of Changes
Other Study ID Numbers:	S308.3.003, Not requested yet
Study First Received:	June 8, 2006
Last Updated:	April 1, 2008
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Czech Republic: State Institute for Drug Control Estonia: The State Agency of Medicine France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut India: Ministry of Health Italy: The Italian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Ministry of Health Portugal: National Pharmacy and Medicines Institute South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Taiwan: Department of Health Thailand: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Lithuania: State Medicine Control Agency - Ministry of Health Malaysia: Ministry of Health

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
Pramipexol
Antioxidants
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 16, 2012