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

NCT01515410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2014-03-10

Study results available
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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

Conditions

Interventions

DRUG

DM-1992

72.5mg carbidopa/230mg levodopa

DRUG

Sinemet IR

Immediate-release tablet containing 25mg carbidopa and 100mg levodopa

Sponsors & Collaborators

  • Depomed

    lead INDUSTRY

Principal Investigators

  • Rekha Sathyanarayana · Depomed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-09-30
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515410 on ClinicalTrials.gov