Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations
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|ClinicalTrials.gov Identifier: NCT01515410|
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Motor Fluctuations||Drug: DM-1992 Drug: Sinemet IR||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||October 2012|
DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
72.5mg carbidopa/230mg levodopa
Active Comparator: Sinemet IR
An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
Drug: Sinemet IR
Immediate-release tablet containing 25mg carbidopa and 100mg levodopa
- The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time. [ Time Frame: Baseline and 10 days for each of the 2 study periods ]
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100.
Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state.
Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.
End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period.
Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515410
|United States, Alabama|
|Birmingham, Alabama, United States|
|United States, Arkansas|
|Little Rock, Arkansas, United States|
|United States, California|
|Long Beach, California, United States|
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, Michigan|
|Bingham Farms, Michigan, United States|
|United States, Ohio|
|Cincinnati, Ohio, United States|
|United States, Texas|
|Dallas, Texas, United States|
|Study Director:||Rekha Sathyanarayana||Depomed|