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 III

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Parkinson's Disease

ChemIDplus related topics:

Pramipexol Pramipexole dihydrochloride SLV-308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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.

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

Responsible Party:	Solvay Pharmaceuticals ( Ellen van Kleef )
Study ID Numbers:	S308.3.003, Not requested yet
First Received:	June 8, 2006
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00335166
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 - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Dopamine

Ganglion Cysts

Movement Disorders

Parkinson Disease

Basal Ganglia Diseases

Central Nervous System Diseases

Parkinsonian Disorders

Neurodegenerative Diseases

Brain Diseases

Pramipexol

Additional relevant MeSH terms:

Neurotransmitter Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Nervous System Diseases

Physiological Effects of Drugs

Antiparkinson Agents

Dopamine Agonists

Protective Agents

Pharmacologic Actions

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00335166