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NCT00335166

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.

Completed Phase 3 Last updated 1 April 2008
What this trial tests

Phase 3 trial testing Pardaprunox in Early Stage Parkinson Disease in 330 participants. Completed in 1 February 2008.

Timeline
1 November 2006
Primary endpoint
1 February 2008
1 February 2008

Quick facts

Lead sponsorSolvay Pharmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment330
Start date1 November 2006
Primary completion1 February 2008
Estimated completion1 February 2008
Sites89 locations across United States, Australia, Czechia, Estonia, France, Germany, India, Italy

Drugs / interventions tested

Conditions studied

Sponsor

Solvay Pharmaceuticals — full company profile →

Who can join

30 and older, any sex, with Early Stage Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
    Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2

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