Trials / Completed
CompletedNCT01515410
Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations
A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Depomed · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DM-1992 | 72.5mg carbidopa/230mg levodopa |
| DRUG | Sinemet IR | Immediate-release tablet containing 25mg carbidopa and 100mg levodopa |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2012-09-01
- Completion
- 2012-10-01
- First posted
- 2012-01-24
- Last updated
- 2014-03-10
- Results posted
- 2014-03-10
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01515410. Inclusion in this directory is not an endorsement.