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

January 27, 2014 updated by: Depomed

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Long Beach, California, United States
    • Illinois
      • Chicago, Illinois, United States
    • Michigan
      • Bingham Farms, Michigan, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Texas
      • Dallas, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
  2. Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
  3. On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
  4. Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
  5. Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
  6. Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
  7. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
  8. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.

Exclusion Criteria:

  1. Patients with atypical or drug-induced Parkinson's disease.
  2. Patients with a known history of hypersensitivity to levodopa or carbidopa.
  3. Patients who receive treatments with dopamine receptor blocking agents
  4. Patients with a history of seizures except of childhood febrile seizure.
  5. Patients with dementia.
  6. Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.
  7. Patients with any history of gastric surgery other than vagotomy and pyloroplasty.
  8. Patients with an immune-compromised state.
  9. Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.
  10. Patients with a calculated creatinine clearance (Clcr) < 50 mL/min using the Cockcroft-Gault equation.
  11. Patients who have a difficulty swallowing tablets.
  12. Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
  13. Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DM-1992
DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
Drug: DM-1992
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 10 days for each of the 2 study periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Depomed

Investigators

  • Study Director: Rekha Sathyanarayana, Depomed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 23, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81-0068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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