A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A

Conditions: Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 13.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders

Registration Number: EUCTR2009-014688-37-PL

Lead Sponsor: Impax Laboratories, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

1.Able to understand and willing to 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 as defined by meeting United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria (Appendix D), 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 C).
5.Mini-Mental State Exam (MMSE, Appendix F) = 26 at Screening.
6.Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:
•Requiring a total daily IR LD dose of at least 400 mg
•Having a minimum dosing frequency of four times per day.
7.Able to differentiate on” state from off” state as defined by at least 75% concordance with a trained 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 (Appendix E).
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 of off” time based on the 3-day PD diaries recorded on the 3 consecutive days immediately prior to Visit 1.
10.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.
11.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, intra uterine device, condom and partner using vaginal spermicide, surgical sterilization (6 months), progestin implant or injection, or postmenopausal female (no menstrual period for > 2 years) or vasectomy (> 6 months).
12.Able and willing to comply with the protocol, including availability for all scheduled clinic visits 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.Subjects who score a combined total 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 if such procedures are anticipated during study participation.
5.Received within 4 weeks of Screening Visit or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
6.Allergic to the excipients of IPX066 (Appendix O).
7.Allergic to Yellow Dye #5 (tartrazine).
8.History of or currently active psychosis.
9.Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
10.Active or history of narrow-angle glaucoma.
11.Subjects with a 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, or neuroleptic malignant syndrome and/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.Unable to swallow large pills (e.g., large vitamin pills).
17.Subjects who have been previously enrolled in IPX066 studies.
18.Subjects who, in the opinion of the clinical investigator, should not participate in the study.
19.Pregnant or breastfeeding.
20.Employees or family members of the investigator, study site or the sponsor.
21.Subjects who are unable to complete the diary.
22.Positive screen on the m-MIDI as defined in Appendix M.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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