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

NCT00335166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2008-04-03

No results posted yet for this study

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.

Conditions

  • Early Stage Parkinson Disease

Interventions

DRUG

Pardaprunox

12-42 mg

DRUG

pramipexole

1.5-4.5 mg

DRUG

Placebo Comparator

Placebo

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States
  • Australia
  • Czechia
  • Estonia
  • France
  • Germany
  • India
  • Italy
  • Lithuania
  • Malaysia
  • Netherlands
  • Poland
  • Portugal
  • South Africa
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00335166 on ClinicalTrials.gov