SLV308 for Treatment of Patients With Early Parkinson's Disease - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00269516

Purpose

This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a 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's Disease	Drug: pardoprunox Drug: Pardoprunox Drug: Placebo	Phase III

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: SLV-308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm 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: 6 months ] [ 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: 6 months ] [ Designated as safety issue: No ]

Enrollment:	468
Study Start Date:	June 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pardoprunox fixed dose 6 mg
2: Experimental	Drug: Pardoprunox fixed dose 12 mg
3: Experimental	Drug: Pardoprunox 12-42mg
4: Placebo Comparator	Drug: Placebo 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,
Early stage of disease, Modified Hoehn & Yahr up to stage III,
UPDRS motor score (part III) 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,
Presence of dyskinesias,
Motor fluctuations or loss of postural reflexes,
Clinically significant abnormalities,
Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
Antipsychotic.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269516

Show 128 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Erik van Leeuwen )
Study ID Numbers:	S308.3.001
Study First Received:	December 22, 2005
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00269516
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Finland: National Agency for Medicines; Romania: National Medicines Agency; Slovakia: State Institute for Drug Control; Sweden: Medical Products Agency; Bulgaria: Bulgarian Drug Agency; Croatia: Ministry of Health and Social Care; Russia: Ministry of Health and Social Development of the Russian Federation; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Ukraine: Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Chile: Instituto de Salud Publica de Chile; Peru: Ministry of Health; Mexico: Federal Commission for Protection Against Health Risks; South Africa: Medicines Control Council; India: Ministry of Health; Canada: Canadian Institutes of Health Research; New Zealand: Medsafe; United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Parkinson's disease

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009