Carbidopa-Levodopa Extended-Release (CD-LD ER) Alone or in Combination With Carbidopa-Levodopa Immediate Release (IR) to IPX066 Followed by Extension Safety Study of IPX066 in Subjects With Advanced Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01411137
First received: August 4, 2011
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to find out how doses of IPX066 required to help people with Parkinson's disease compare to those required for carbidopa-levodopa sustained-release tablets (also known as Sinemet® CR).


Condition Intervention Phase
Parkinson's Disease
Drug: IPX066
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Conversion Study of Carbidopa-Levodopa Extended-Release (CD-LD ER) Taken Alone or in Combination With Carbidopa-Levodopa Immediate Release (IR) to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Subjects With Advanced Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:
  • Patient Global Impression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient reported outcome

  • Clinical Global Impression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinician reported outcome

  • Parkinson's Disease Questionnaire- 8 (PDQ-8) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Disease severity questionnaire


Enrollment: 43
Study Start Date: August 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPX066 Drug: IPX066
CD-LD extended release
Other Name: CD-LD extended release capsules

Detailed Description:

Part 1 - This study is a multicenter open-label study. Subjects will be converted from their current treatment to IPX066 over a 6-week period. Up to 40 subjects will be enrolled in the study. Subjects will be entered into one of two cohorts. Approximately 24 subjects will enroll in Cohort 1 (non- Objective Parkinson's Disease Measurement (OPDM) subjects) and up-to 16 subjects at selected sites will enroll in Cohort 2 (OPDM/PK subjects). Along with the OPDM measurements, PK blood samples may also be collected from these subjects.

Part 2 - Following the successful completion of Part 1 of the study, eligible subjects may participate in Part 2, a 6-month open-label extension study.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with idiopathic PD without any known cause for Parkinsonism.
  2. At least 30 years old at the time of PD diagnosis.
  3. Currently being treated with:

    • an LD dosing frequency of at least four times a day
    • at least one dose of CD-LD ER daily
    • requiring a total daily LD dose of at least 400 mg
    • stable regimen for at least 4 weeks prior to Screening
  4. Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
  5. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.

Exclusion Criteria:

  1. Pregnant or breastfeeding
  2. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
  3. Nonresponsive to LD therapy.
  4. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
  5. Planning to take during participation in the clinical study: any controlled-release LD product, additional CD or benserazide, entacapone or tolcapone, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
  6. Any evidence of suicidal behavior within 6 months of entering the study.
  7. Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
  8. History of or currently active psychosis.
  9. Active or history of peptic ulcers or surgical procedure of the stomach, the small intestine or the large intestine.
  10. Active or history of narrow-angle glaucoma.
  11. History of malignant melanoma or a suspicious undiagnosed skin lesion.
  12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
  13. Abnormal kidney function
  14. Severe hepatic impairment.
  15. Received any investigational medications during the 4 weeks prior to Screening.
  16. Previously enrolled in IPX066 studies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411137

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Coastal Neurological Medical Group
La Jolla, California, United States, 92037
The Parkinson's Institute
Sunnyvale, California, United States, 94085
United States, Florida
Renstar Medical Research
Ocala, Florida, United States, 34471
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Nevada
University of Nevada School of Medicine
Las Vegas, Nevada, United States, 89102
United States, New York
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, United States, 11725
United States, Wisconsin
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Michael J. Fox Foundation for Parkinson's Research
Investigators
Study Chair: Impax Study Director Impax Pharmaceuticals Division (Impax) , a Division of Impax Laboratories Inc.
  More Information

No publications provided

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01411137     History of Changes
Other Study ID Numbers: IPX066-B11-01
Study First Received: August 4, 2011
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014