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

• Register: EUCTR
• Last refreshed on: 14 March 2022
• Main ID: EUCTR2015-003887-34-IT
• Date of registration: 21/01/2021
• Prospective Registration: No
• Primary sponsor: KYOWA HAKKO KIRIN PHARMA, INC.
• Public title: A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease
• Scientific title: A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease - A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinso
• Date of first enrolment: 25/03/2016
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003887-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Open Label Safety; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Czech Republic, Germany, Israel, Italy, Poland, Serbia, United States

Contacts

• Name: Clinical Trial Help Desk
• Affiliation: Kyowa Kirin Pharmaceutical Development, Inc.

• Name: Clinical Trial Help Desk
• Affiliation: Kyowa Kirin Pharmaceutical Development, Inc.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Moderate to severe Parkinson's disease
MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Istradefylline
CAS Number: 155270-99-8
Current Sponsor code: KW-6002
Other descriptive name: ISTRADEFYLLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Istradefylline
CAS Number: 155270-99-8
Current Sponsor code: KW-6002
Other descriptive name: ISTRADEFYLLINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Secondary Objective: Not applicable

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).

Timepoint(s) of evaluation of this end point: Screening, Baseline, Weeks 12, 26, and 52 and 30 day follow up visit

Primary end point(s): Safety:
• AEs;
• Clinical laboratory assessments.

Secondary Outcome(s)

Secondary end point(s): Efficacy:
¿ Change from Baseline in the score on the PGI-I Scale

Timepoint(s) of evaluation of this end point: Weeks 12, 26, and 52.

Secondary ID(s)

N/A

6002-018

NCT02610231

2015-003887-34-DE

Source(s) of Monetary Support

Kyowa Kirin Pharmaceutical Development, Inc.

Ethics review

Status: Approved
Approval date: 12/02/2016
Contact:

Results

• Results available: Yes
• Date Posted: 03/01/2019
• Date Completed: 20/12/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003887-34/results