A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 (CLE with OLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT01130493
First received: May 24, 2010
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.


Condition Intervention Phase
Parkinson's Disease
Drug: IPX066
Drug: Carbidopa/Levodopa/Entacapone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Parkinson's Disease Patient Diary [ Time Frame: Weeks 1-11 ] [ Designated as safety issue: No ]
    A subject-completed diary of Parkinson's Disease(PD) symptoms.


Enrollment: 74
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPX066
IPX066
Drug: IPX066
IPX066
Active Comparator: Carbidopa/Levodopa/Entacapone
Carbidopa/Levodopa/Entacapone
Drug: Carbidopa/Levodopa/Entacapone
Carbidopa/Levodopa/Entacapone
Other Name: Stalevo

Detailed Description:

This is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.

  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 Parkinson's Disease (PD).
  2. At least 30 years old at the time of PD diagnosis.
  3. Currently being treated with carbidopa/levodopa/entacapone (CLE) and on a stable regimen of conventional LD for at least 4 weeks and:

    • Requiring a total daily levodopa (LD) dose of at least 400 mg
    • Having a minimum dosing frequency of four times per day.
    • Individual CD-LD or CLE doses that contain an LD dose which is a multiple of 50 mg.
  4. Able to differentiate "on" state from "off" state.
  5. Have predictable "off" periods.
  6. Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are 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.
  7. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.

Exclusion Criteria:

  1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
  2. Nonresponsive to LD therapy.
  3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
  4. Received within 4 weeks of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
  5. Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
  6. History of or currently active psychosis.
  7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
  8. Active or history of narrow-angle glaucoma.
  9. History of malignant melanoma or a suspicious undiagnosed skin lesion.
  10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
  11. Received any investigational medications during the 4 weeks prior to Screening.
  12. Unable to swallow large pills (e.g., large vitamin pills).
  13. Pregnant or breastfeeding.
  14. Subjects who are unable to complete a symptom diary.
  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: NCT01130493

Locations
United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
The Parkinson's Institute in Sunnyvale
Sunnyvale, California, United States, 94085
United States, Florida
UM Movement Disorders Center
Miami, Florida, United States, 33136
Charlotte Neurological Services
Port Charlotte, Florida, United States, 33980
USF Parkinson's and Movement Disorders Center
Tampa, Florida, United States, 33606
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Nevada
University Health Systems
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
Kingston Neurological Associates
Kingston, New York, United States, 12401
United States, Ohio
University Neurology, Inc
Cincinnati, Ohio, United States, 45219
United States, Virginia
Sentara Neurological Associates
Virginia Beach, Virginia, United States, 23456
United States, Washington
Booth Gardner Parkinson's Care Center
Kirkland, Washington, United States, 98034
France
Hôpital Gabriel Montpied-Service de Neurologie A-
Clermont-Ferrand Cedex 1, France, 63003
Service de neurologie-Hôpital de la Timone-
Marseille, France, 13385
Germany
Praxis für Neurologie, Psychiatrie und Psychotherapie Achim
Achim, Germany, 28832
Praxis Dres. Bitter/Schumann
Bochum, Germany, 44805
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675
Klinik für Neurologie, Stadtroda
Stadtroda, Germany, 07646
RKU, Neurologische Klinik der Universität Ulm
Ulm, Germany, 89081
Italy
Casa di Cura Villa Margherita
Arcugnano, Italy, 36057
San Raffaele Cassino, San Raffaele Cassino,
Cassino, Italy, 03043
Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio
Chieti, Italy, 66013
Ospedale della Misericordia
Grosseto, Italy, 58100
IRCCS San Raffaele Pisana
Roma, Italy, 163
Sponsors and Collaborators
IMPAX Laboratories, Inc.
Investigators
Study Director: Impax Study Director Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)
  More Information

No publications provided

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01130493     History of Changes
Other Study ID Numbers: IPX066-B09-06
Study First Received: May 24, 2010
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
Entacapone
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
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists

ClinicalTrials.gov processed this record on September 30, 2014