Status:
COMPLETED
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.
Detailed Description
A randomized, double-blind, placebo-controlled, fixed-dose, parallel-arm study of three doses of IPX066 versus placebo. Total of 427 subjects were screened and 381 were randomized and received one of...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT00880620
Start Date
April 1 2009
End Date
November 1 2010
Last Update
October 29 2019
Active Locations (60)
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1
University of Alabama at Birmingham, Dept. of Neurology
Birmingham, Alabama, United States, 35233
2
HOPE Research Institute, LLC
Phoenix, Arizona, United States, 85050
3
Collaborative NeuroScience Network, Inc.
Garden Grove, California, United States, 92845
4
Coastal Neurological Medical Group
La Jolla, California, United States, 92037