At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
DM-1992 +1 moredrug
Likely dose
DM-1992 72.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating DM-1992 and Sinemet IR for Parkinson's Disease and Motor Fluctuations. Completed, enrolled 34 participants across 7 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease, Motor Fluctuations
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionSep 2012
Study CompletionOct 2012
TodayJul 2026
First PostedJan 24, 2012
Enrollment StartJan 1, 2012
Primary CompletionSep 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.4 years ago
Interventions
DM-1992drug
72.5mg carbidopa/230mg levodopa
Sinemet IRdrug
Immediate-release tablet containing 25mg carbidopa and 100mg levodopa