A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 239

Inclusion Criteria

• Subjects who have given written informed consent;
• Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014;
• Subjects who are currently taking levodopa combination carbidopa/levodopa or benserazide/levodopa) therapy plus at least one adjunctive PD medication;
• Women of child-bearing potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double barrier methods [such as condom plus diaphragm, condom plus spermicide foam, condom plus sponge], or intra-uterine devices), and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
– WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal (defined as amenorrhea = 24 consecutive months or a serum follicle-stimulating hormone [FSH] = 30 IU/L in the absence of hormone replacement therapy.
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

• Subjects whose treatment compliance was less than 70% throughout their enrollment in Study No. 6002-014;
• Subjects who are currently treated with apomorphine and/or dopamine receptor antagonists (paliperidone, clozapine, risperidone, olanzapine, quetiapine [except for 100 mg/d or less for levodopa- or PD-induced hallucinations], ziprasidone, aripiprazole, asenapine, and lurasidone, etc.) or direct gastrointestinal levodopa infusion;
• Subjects who have been treated within 30 days before Baseline (or five half-lives of the compound, if longer) with any investigational agents other than istradefylline;
• Subjects who have undergone a neurosurgical procedure for PD (e.g., pallidotomy, thalamotomy, or deep brain stimulation);
• Subjects who are currently receiving another A2A antagonist (except for caffeine which is allowed);
• Subjects who are taking potent CYP3A4 inhibitors (systemic antifungals such as ketoconazole);
• Subjects who are taking potent CYP3A4 inducers (such as St John’s Wort and rifampin);
• Subjects who have had a diagnosis of cancer or evidence of continued malignancy within the past three years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen post resection);
• Subjects with major protocol deviations in Study No. 6002-014 (subjects who failed to meet any of the inclusion criteria, subjects who met any of the exclusion criteria or subjects who met the criteria for subject withdrawal but who were not withdrawn);
• Subjects who, for any reason, are judged by the Investigator to be inappropriate for this study, including a subject who is unable to communicate or to cooperate with the Investigator or who has/had a clinically significant illness or abnormal physical examination that may compromise the safety of the subject during the study or affect the ability of the subject to adhere to study procedures;
• Subjects who have clinical laboratory test results that are clinically unacceptable by the Investigator, or who have an alanine aminotransferase and/or an aspartate aminotransferase level > 3 times the upper limit of normal (ULN), and serum total bilirubin > 2 times the ULN at Screening;
• Subjects who have untreated major depressive disorder;
• Subjects who have a history of seizures or seizure disorders;
• Subjects who have a history of neuroleptic malignant syndrome;
• Subjects with suicidal behavior within the previous month;
• Subjects who have a history of drug or alcohol abuse or dependence within the last year by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision;
• Subjects who are pregnant (confirmed by beta human chorionic gonadotropin [ß-HCG]), plan to become pregnant, or are breastfeeding.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of oral istradefylline 20 to 40 mg/d as treatment for subjects with moderate to severe Parkinson¿s Disease (PD).;Secondary Objective: Not applicable;Primary end point(s): Safety:<br>• AEs;<br>• Clinical laboratory assessments.;Timepoint(s) of evaluation of this end point: Screening, Baseline, Weeks 12, 26, and 52 and 30 day follow up visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy:<br>¿ Change from Baseline in the score on the PGI-I Scale;Timepoint(s) of evaluation of this end point: Weeks 12, 26, and 52.

Related Trials