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news.Depomed has commenced a Phase II trial of DM-1992, a gastric-retentive, extended-release formulation of carbidopa/levodopa, in patients with advanced Parkinson's disease with motor fluctuations.
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The randomized, active-controlled, open-label trial is designed to enroll at 8 US clinical centers up to 45 patients with Parkinson’s disease with motor fluctuations.
The crossover study will test DM-1992 dosed twice daily against a generic version of immediate-release carbidopa/levodopa dosed as needed.
The study will assess efficacy, safety and pharmacokinetic variables.
The primary endpoint for the study is change in off time as measured by patient self-assessment and clinician assessment.
Depomed chief medical officer and research and development vice president Michael Sweeney said they believe DM-1992 may meet a significant unmet need of Parkinson’s patients.