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

Launched by IMPAX LABORATORIES, LLC · Apr 13, 2009

Keywords

ClinConnect Summary

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 the four treatment groups (1) placebo (N=92), (2) IPX066 145 mg LD (N=87) (3) IPX066 245 mg LD (N=104) (4) IPX066 390 mg LD (N=98) three times a day.

Study duration is approximately 30 weeks for each subject including 4 weeks of titration (up to 3 weeks of dose escalation and I week of stabilization for safe escalation to the allocated dose), and 26 weeks of maintenance.

During the titration...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Diagnosed with idiopathic PD.
• • 3. 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.
• • 4. 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.
• • 5. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
• • 6. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
• Exclusion Criteria:
• • 1. Pregnant or breastfeeding.
• • 2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
• • 3. Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
• • 4. Use of nonselective MAO inhibitors.
• • 5. Use of dopamine agonists within 30 days prior to Screening.
• • 6. Unable to tolerate a placebo regimen, in the Investigator's opinion.
• • 7. Treatment of psychosis with any antipsychotic.
• • 8. History of seizure or epilepsy.
• • 9. Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
• • 10. History of narrow-angle glaucoma.
• • 11. Subjects with a history of malignant melanoma.
• • 12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
• • 13. Received any investigational medications during the 30 days prior to Screening.