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

NCT ID: NCT01515410

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-10-31

Brief 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

Parkinson's Disease; Motor Fluctuations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DM-1992

DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)

Group Type: EXPERIMENTAL

DM-1992

Intervention Type: DRUG

72.5mg carbidopa/230mg levodopa

Sinemet IR

An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)

Group Type: ACTIVE_COMPARATOR

Sinemet IR

Intervention Type: DRUG

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

Interventions

DM-1992

72.5mg carbidopa/230mg levodopa

Intervention Type: DRUG

Sinemet IR

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Depomed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rekha Sathyanarayana

Role: STUDY_DIRECTOR

Depomed

Locations

Birmingham, Alabama, United States

Little Rock, Arkansas, United States

Long Beach, California, United States

Chicago, Illinois, United States

Bingham Farms, Michigan, United States

Cincinnati, Ohio, United States

Dallas, Texas, United States

Countries

United States

Other Identifiers

81-0068

Identifier Type: -

Identifier Source: org_study_id