drugset / Trial / NCT01515410
Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations
RandomizedCrossoverOpen-labelTreatment
Summary
The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by: * "ON" time with no dyskinesia or non-troublesome dyskinesia * "OFF" time
Timeline
- Start
- 2012-01
- Primary completion
- 2012-09
- Completion
- 2012-10
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry LEAST_SQUARES_MEAN DM-1992: -5.52 (-10.42 to -0.63) percentage of time NCT01515410 ↗
registry analysis (superiority or other test); DM-1992 vs Sinemet IR; p = 0.0471; Difference in Least Squares Mean -6.86 (95% CI -13.62 to -0.09); ANCOVA; NCT01515410 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbidopa | Unknown | 25 mg | — |
| Subject | Carbidopa | Unknown | 72.5 mg | — |
| Subject | Levodopa | Unknown | 100 mg | — |
| Subject | Levodopa | Unknown | 230 mg | — |