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Clinical Trials/NCT00134251
NCT00134251
Completed
Phase 3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's Disease

Solvay Pharmaceuticals10 sites in 3 countriesOctober 2005
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ConditionsParkinson's Disease
DrugsSLV308

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Solvay Pharmaceuticals
Locations
10
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
TBD
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients who have signed an informed consent; diagnosis of idiopathic PD.
  • •Presence of recognizable "on" and "off" stages
  • •Minimum hours of "off" time per day of 2.5 hours
  • •Able to keep diaries.

Exclusion Criteria

  • •Unclear diagnosis or a suspicion of other parkinsonian syndromes
  • •Have undergone surgical treatment for PD
  • •History of non-response to L-dopa.

Outcomes

Primary Outcomes

Not specified

Study Sites (10)

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