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A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 | Clinical Trials | Clareo Health

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

A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease

NCT01130493•Impax Laboratories, LLC

View on ClinicalTrials.gov

Summary

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

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

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (24)

Margolin Brain Institute

Fresno, California, United States

The Parkinson's Institute in Sunnyvale

Sunnyvale, California, United States

UM Movement Disorders Center

Miami, Florida, United States

Charlotte Neurological Services

Port Charlotte, Florida, United States

USF Parkinson's and Movement Disorders Center

Tampa, Florida, United States

Quest Research Institute

Bingham Farms, Michigan, United States

University Health Systems

Las Vegas, Nevada, United States

Parkinson's Disease and Movement Disorders Center of Long Island

Commack, New York, United States

Kingston Neurological Associates

Kingston, New York, United States

University Neurology, Inc

Cincinnati, Ohio, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

January 1, 2012

Completion Date

January 1, 2012

Last Updated

October 29, 2019

Enrollment

110

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

IPX066

DRUG

CLE

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations