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SLV308 for Treatment of Patients With Early Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00269516
First received: December 22, 2005
Last updated: August 28, 2008
Last verified: August 2008
History of Changes
  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 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 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

Resource links provided by NLM:

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: 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
Experimental: 1 Drug: pardoprunox
fixed dose 6 mg
Experimental: 2 Drug: Pardoprunox
fixed dose 12 mg
Experimental: 3 Drug: Pardoprunox
12-42mg
Placebo Comparator: 4 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

No publications provided by Solvay Pharmaceuticals

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

Responsible Party: Erik van Leeuwen, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00269516     History of Changes
Other Study ID Numbers: S308.3.001
Study First Received: December 22, 2005
Last Updated: August 28, 2008
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
Finland: Finnish Medicines Agency
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 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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 21, 2013