Studies To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
- Study 1: Early Parkinson’s disease
- Study 2: Advanced Parkinson’s disease
What is the purpose of these trials?
These studies examine the efficacy of IPX066 as compared to placebo in Parkinson's disease.
Dates: April 2009 - July 2010
Study Status: Recruiting
Who can participate?
Ages Eligible: 30 Years and older
Gender Eligible: Both
- 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-na2ve: 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.
- 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.
Sponsor: IMPAX Laboratories, Inc.
Phase: Phase 3
Clinicaltrials.gov ID: NCT00880620
Study HIC # 0905005200
For more information about this trial, contact:
Duarte Machado, M.D. Study Coordinator