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

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

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

Key facts

Study ID

NCT01130493

Run by

Impax Laboratories, LLC

People needed

110

Starts

2010-05-01

Expected to finish

2012-01-01

Last updated by the study team

2019-10-29

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with idiopathic Parkinson's Disease (PD).
• At least 30 years old at the time of PD diagnosis.
• 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.
• Able to differentiate "on" state from "off" state.
• Have predictable "off" periods.
• 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.
• Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.

You may not qualify if…

• Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
• Nonresponsive to LD therapy.
• Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
• 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.
• Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
• History of or currently active psychosis.
• Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
• Active or history of narrow-angle glaucoma.
• History of malignant melanoma or a suspicious undiagnosed skin lesion.
• History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
• Received any investigational medications during the 4 weeks prior to Screening.
• Unable to swallow large pills (e.g., large vitamin pills).
• Pregnant or breastfeeding.
• Subjects who are unable to complete a symptom diary.

Where it is running

• 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
• Sentara Neurological Associates — Virginia Beach, Virginia, United States
• Booth Gardner Parkinson's Care Center — Kirkland, Washington, United States
• Hôpital Gabriel Montpied-Service de Neurologie A- — Clermont-Ferrand, France
• Service de neurologie-Hôpital de la Timone- — Marseille, France
• Praxis für Neurologie, Psychiatrie und Psychotherapie Achim — Achim, Germany
• Praxis Dres. Bitter/Schumann — Bochum, Germany
• Klinikum rechts der Isar der Technischen Universität München — München, Germany
• Klinik für Neurologie, Stadtroda — Stadtroda, Germany
• RKU, Neurologische Klinik der Universität Ulm — Ulm, Germany
• Casa di Cura Villa Margherita — Arcugnano, Italy
• San Raffaele Cassino, San Raffaele Cassino, — Cassino, Italy
• Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio — Chieti, Italy
• Ospedale della Misericordia — Grosseto, Italy
• IRCCS San Raffaele Pisana — Roma, Italy

Full record on ClinicalTrials.gov

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