A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND

• Conditions: Idiopathic Parkinson’s Disease (paralysis agitans); MedDRA version: 9.1Level: LLTClassification code 10061536

• Registration Number: EUCTR2009-017238-39-IT
• Lead Sponsor: IMPAX LABORATORIES, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-13
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Able to understand and willing to sign an ICF and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent, if applicable. 2. Diagnosed with idiopathic PD meeting United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria (Appendix M), without any known cause for Parkinsonism. 3. At least 30 years old at the time of PD diagnosis. 4. Hoehn and Yahr Staging I-IV in the on” state (Appendix N). 5. Mini-Mental State Exam (MMSE, Appendix O) = 26 at Screening. 6. Currently being treated with CLE in a dosing regimen which includes an immediate release LD product (e.g., Stalevo or standard Sinemet 25 mg-100 mg plus entacapone). Subject must be on a stable regimen of CLE (or benserazide-levodopa-entacapone) for at least 4 weeks at: • a total daily levodopa dose of at least 400 mg • a minimum CLE 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. 7. Able to differentiate on” state from off” state as defined by at least 75% concordance with an experienced rater in on/off” ratings for at least four ratings over the 4-hour training period. The concordance must include at least one on” and one off” rating and must be achieved within two 4- hour training sessions. 8. Have predictable off” periods defined by a yes” response to Question #36 on the UPDRS. 9. Prior to the Screening Visit, the subject should have an average of at least 2.5 cumulative hours per day of off” time during the waking hours for the last 2 weeks (by history). At Visit 1 the subject must have an average of at least 2.5 hours over 3 days and at least 1 hour each day ofoff” time based on the 3-day PD diaries recorded on the 3 consecutive days immediately prior to Visit 1. 10. At least 10% increase in finger tapping rate (number of taps over a 1- minute period) during the on” state when compared to the off” state at Screening. 11. Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is 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. 12. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study. Medically acceptable methods of contraception that may be used by the subject and/or partner include, but are not limited to: abstinence, oral contraception, NuvaRing or transdermal systems, diaphragm with vaginal spermicide, intrauterine device, condom and partner using vaginal spermicide, surgical sterilization (6 months), progestin implant or injection, postmenopausal female (no menstrual period for > 2 years) or vasectomy (> 6 months). 13. Able and willing to comply with the protocol, including availability for all scheduled clinic visits, diary data and blood sample collections, and telephone calls
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome (e.g., vascular, toxin- or medication-induced, metabolic, or infectious) or other neurodegenerative disorder with Parkinsonism (e.g., progressive supranuclear palsy, corticobasal degeneration, multiple-system atrophy). 2. Nonresponsive to LD therapy. 3. Combined total score of = 5 on Questions #32, #33, and #34 of the UPDRS or a score of = 3 on Question #33 of the UPDRS. 4. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation), or such procedures are anticipated during study participation. 5. 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. 6. Planning to take during participation in the clinical study: Any CD or LD products not provided by the study, e.g., Lodosyn, benserazide (Serazide), Sinemet CR or any controlled-release LD products, Parcopa? or any fast-dissolving LD-containing products, or any entacapone not provided by the study. 7. Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice. 8. Active or history of psychosis. 9. Active or history of medical conditions such as peptic ulcers or prior surgery (e.g., bowel procedures) that would interfere with LD absorption. 10. Active or history of narrow-angle glaucoma. 11. History of malignant melanoma or a suspicious undiagnosed skin lesion which, in the opinion of the Investigator, could be melanoma. 12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, neuroleptic malignant syndrome or nontraumatic rhabdomyolysis. 13. Abnormal kidney function (e.g., serum creatinine level = 1.5 times the upper limit of normal) at Screening or requires dialysis. 14. Severe hepatic impairment. 15. Received any investigational medications during the 4 weeks prior to Screening. 16. Donated blood or plasma within 28 days prior to Visit 1 or planning to donate blood or plasma during the study or within 4 weeks after completing the study. 17. Unable to swallow large pills (e.g., large vitamin pills). 18. Previously enrolled in IPX066 studies. 19. Pregnant or breastfeeding. 20. Employees or family members of the Investigator, study site, or sponsor. 21. Unable to complete the PD diary. 22. In the opinion of the clinical Investigator, the subject should not participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified