A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

Key facts

Study ID

NCT00880620

Run by

Impax Laboratories, LLC

People needed

381

Starts

2009-04-01

Expected to finish

2010-11-01

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…

• Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.
• Diagnosed with idiopathic PD.
• LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
• If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.
• Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
• Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.

You may not qualify if…

• Pregnant or breastfeeding.
• Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
• Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
• Use of nonselective MAO inhibitors.
• Use of dopamine agonists within 30 days prior to Screening.
• Unable to tolerate a placebo regimen, in the Investigator's opinion.
• Treatment of psychosis with any antipsychotic.
• History of seizure or epilepsy.
• Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
• History of narrow-angle glaucoma.
• Subjects with a history of malignant melanoma.
• History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
• Received any investigational medications during the 30 days prior to Screening.

Where it is running

• HOPE Research Institute, LLC — Phoenix, Arizona, United States
• Collaborative NeuroScience Network, Inc. — Garden Grove, California, United States
• Coastal Neurological Medical Group — La Jolla, California, United States
• Coordinated Clinical Research — La Jolla, California, United States
• The Parkinson's Institute — Sunnyvale, California, United States
• Yale Neurology Clinics, Temple Medical Center — New Haven, Connecticut, United States
• Bradenton Research Center, Inc. — Bradenton, Florida, United States
• Sunrise Clinical Research, Inc. — Hollywood, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Charlotte Neurological Services — Port Charlotte, Florida, United States
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Idaho Elks Rehabilitation Hospital — Boise, Idaho, United States
• Rush University Medical Center, Dept. of Neurological Sciences — Chicago, Illinois, United States
• Landon Center on Aging, Dept. of Neurology, Parkinson's Disease Center — Kansas City, Kansas, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Quest Research Institute — Bingham Farms, Michigan, United States
• Struthers Parkinson's Center — Golden Valley, Minnesota, United States
• UMDNJ Robert Wood Johnson Medical Center, Department of Neurology — New Brunswick, New Jersey, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Columbia University — New York, New York, United States
• State University of New York Upstate Medical University, Dept. of Neurology — Syracuse, New York, United States
• Duke University Medical Center Movement Disorders Center — Durham, North Carolina, United States
• University of Toledo — Toledo, Ohio, United States
• University of Alabama at Birmingham, Dept. of Neurology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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