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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Depomed
ClinicalTrials.gov Identifier:
NCT01515410
First received: January 11, 2012
Last updated: January 27, 2014
Last verified: November 2012
  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 Intervention Phase
Parkinson's Disease
Motor Fluctuations
Drug: DM-1992
Drug: Sinemet IR
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:


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 Percent "OFF" Time. [ Time Frame: Baseline and 10 days for each of the 2 study periods ] [ Designated as safety issue: Yes ]

    "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.



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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515410

Locations
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
Sponsors and Collaborators
Depomed
Investigators
Study Director: Rekha Sathyanarayana Depomed
  More Information

No publications provided

Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT01515410     History of Changes
Other Study ID Numbers: 81-0068
Study First Received: January 11, 2012
Results First Received: November 20, 2013
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Depomed:
Parkinson's disease
PD
stage2/3Parkinson's
Advanced Parkinson's Disease with Motor Fluctuations

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014