SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
Completed · Phase 3 · Has a placebo group
Conditions studied: Advanced Stage Parkinson's Disease
In brief
This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance 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
- NCT00406588
- Run by
- Solvay Pharmaceuticals
- People needed
- 295
- Starts
- 2007-03-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2015-02-27
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of idiopathic Parkinson's Disease,
- advance stage of disease,
- Modified Hoehn \& Yahr stage II-IV,
- presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization
You may not qualify if…
- 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
- Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
- Previous surgery for the treatment of PD
Where it is running
- Site 220 — La Jolla, California, United States
- Site 211 — San Francisco, California, United States
- Site 214 — Fort Lauderdale, Florida, United States
- Site 218 — Gainsville, Florida, United States
- Site 213 — Tampa, Florida, United States
- Site 219 — Augusta, Georgia, United States
- Site 221 — Chicago, Illinois, United States
- Site 216 — Kansas City, Kansas, United States
- Site 224 — Lexington, Kentucky, United States
- Site 212 — East Lansing, Michigan, United States
- Site 217 — St Louis, Missouri, United States
- Site 222 — Durham, North Carolina, United States
- Site 210 — Toledo, Ohio, United States
- Site 215 — Houston, Texas, United States
- Site 100 — Buenos Aires, Argentina
- Site 101 — Buenos Aires, Argentina
- Site 102 — Buenos Aires, Argentina
- Site 103 — Buenos Aires, Argentina
- Site 106 — Buenos Aires, Argentina
- Site 107 — Buenos Aires, Argentina
- Site 109 — Buenos Aires, Argentina
- Site 105 — Córdoba, Argentina
- Site 104 — Mar del Plata, Argentina
- Site 108 — Santa Fe, Argentina
- Site 223 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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