Study in advanced Parkinson's disease patients with predictable motor fluctuations (clinicaltrials.gov) - Nov 11, 2012 - P2, N=34; Sponsor: Depomed; Active, not recruiting -> Completed
Trial completion • Parkinson's Disease
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This study has been completed.
Sponsor:
Depomed
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT01515410
First received: January 11, 2012
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
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
Parkinson's Disease
Motor Fluctuations
Intervention
Drug: DM-1992
Drug: Sinemet IR
Phase
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Resource links provided by NLM:
Genetics Home Reference related topics: Parkinson disease Perry syndrome
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Levodopa Carbidopa
U.S. FDA Resources
Further study details as provided by Depomed:
Primary Outcome Measures:
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 patients "ON" time with no dyskinesia or non-troublesome dyskinesia and "OFF" time [ Time Frame: 10 days treatment ] [ Designated as safety issue: Yes ]
Ptdiary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state.
Clinician-Assess efficacy at pre-dose,every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits.
Secondary Outcome Measures:
Secondary objective is pharmacokinetics measures [ Time Frame: 24hours ] [ Designated as safety issue: No ]
Pharmacokinetic parameters will be-
AUC0-t
Cmax
Cmin
tmax
Fluctuation index defined as the ratio of Cmax/Cmin
Deviation from the average LD concentration
Relation between the efficacy and duration of concentration above certain level(eg.300ng/mL & 1000ng/mL)will be explored.
Enrollment: 34
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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