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Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations

Parkinson's Disease Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01515410
Study type Interventional
Source Depomed
Contact
Status Completed
Phase Phase 2
Start date January 2012
Completion date October 2012
View Details
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