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

Completed · Phase 3 · Has a placebo group

Conditions studied: Early Stage Parkinson Disease

In brief

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.

Key facts

Study ID

NCT00335166

Run by

Solvay Pharmaceuticals

People needed

330

Starts

2006-11-01

Expected to finish

2008-02-01

Last updated by the study team

2008-04-03

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn \& Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 10 at baseline.

You may not qualify if…

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
• Patients who have undergone surgery for the treatment of PD,
• Current presence of dyskinesias,
• Motor fluctuations or loss of postural reflexes,
• A history of non-response to an adequate course of l-dopa or a dopamine agonist,
• Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.

Where it is running

• 413 — Oceanside, California, United States
• 408 — Oxnard, California, United States
• 422 — New Haven, Connecticut, United States
• 403 — Boca Raton, Florida, United States
• 411 — Sarasota, Florida, United States
• 421 — Augusta, Georgia, United States
• 410 — Fort Wayne, Indiana, United States
• 417 — Lexington, Kentucky, United States
• 405 — Boston, Massachusetts, United States
• 420 — Boston, Massachusetts, United States
• 415 — Grand Rapids, Michigan, United States
• 416 — Golden Valley, Minnesota, United States
• 406 — Minneapolis, Minnesota, United States
• 418 — Albany, New York, United States
• 424 — Charlotte, North Carolina, United States
• 412 — Raleigh, North Carolina, United States
• 303 — Bedford Park, Australia
• 304 — Cheltenham, Australia
• 301 — Concord, Australia
• 302 — Westmead, Australia
• 315 — Kralove, Czechia
• 313 — Olomouc, Czechia
• 310 — Ostrava, Czechia
• 314 — Ostrava, Czechia
• 419 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.