Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

NCT ID: NCT02610231

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-20

Brief Summary

This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.

Conditions

Idiopathic Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Istradefylline 20 mg or 40 mg

Treatment for 52 weeks

Group Type: EXPERIMENTAL

Istradefylline 20 mg or 40 mg

Intervention Type: DRUG

Istradefylline 20 or 40 mg

Interventions

Istradefylline 20 mg or 40 mg

Istradefylline 20 or 40 mg

Intervention Type: DRUG

Other Intervention Names

KW-6002

Eligibility Criteria

Inclusion Criteria

1. Written informed consent;

2. Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period;

3. Currently taking levodopa combination (carbidopa/levodopa or benserazide/levodopa) therapy plus at least one adjunctive PD medication;

4. Women of child-bearing potential (WOCBP) must use a reliable method of contraception and have a negative serum pregnancy test at Screening;

2. Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion;

3. Subject who have had neurosurgical operation for PD;

4. Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers;

5. 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 normal prostate-specific antigens post resection).

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Hakko Kirin Pharma, Inc.

INDUSTRY

Sponsor Role: collaborator

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyowa Hakko Kirin Pharma, Inc.

Role: STUDY_DIRECTOR

Kyowa Hakko Kirin Pharma, Inc.

Locations

Kyowa PD Site

Phoenix, Arizona, United States

Kyowa PD Site

Sun City, Arizona, United States

Kyowa PD Site

Tucson, Arizona, United States

Kyowa PD Site

Fountain Valley, California, United States

Kyowa PD Site

Los Angeles, California, United States

Kyowa PD Site

Oxnard, California, United States

Kyowa PD Site

Torrance, California, United States

Kyowa PD Site

Englewood, Colorado, United States

Kyowa PD Site

Danbury, Connecticut, United States

Kyowa PD Site

Boca Raton, Florida, United States

Kyowa PD Site

Port Charlotte, Florida, United States

Kyowa PD Site

Tampa, Florida, United States

Kyowa PD Site

Atlanta, Georgia, United States

Kyowa PD Site

Augusta, Georgia, United States

Kyowa PD Site

Des Moines, Iowa, United States

Kyowa PD Site

Kansas City, Kansas, United States

Kyowa PD Site

Boston, Massachusetts, United States

Kyowa PD Site

West Bloomfield, Michigan, United States

Kyowa PD Site

Albany, New York, United States

Kyowa PD Site

New York, New York, United States

Kyowa PD Site

Asheville, North Carolina, United States

Kyowa PD Site

Durham, North Carolina, United States

Kyowa PD Site

Toledo, Ohio, United States

Kyowa PD Site

Calgary, Alberta, Canada

Kyowa PD Site

Toronto, Ontario, Canada

Kwoya PD Site

Brno, , Czechia

Kyowa PD Site

Litomyšl, , Czechia

Kyowa PD Site

Prague, , Czechia

Kyowa PD Site

Prague, , Czechia

Kyowa PD Site

Beelitz-Heilstätten, , Germany

Kyowa PD Site

Bremerhaven, , Germany

Kyowa PD Site

Dresden, , Germany

Kyowa PD Site

Haag, , Germany

Kyowa PD Site

Kassel, , Germany

Kyowa PD Site

München, , Germany

Kyowa PD Site

Haifa, , Israel

Kyowa PD Site

Jerusalem, , Israel

Kyowa PD Site

Ramat Gan, , Israel

Kyowa PD Site

Tel Aviv, , Israel

Kyowa PD Site

Grosseto, , Italy

Kyowa PD Site

Pavia, , Italy

Kyowa PD Site

Pisa, , Italy

Kyowa PD Site

Roma, , Italy

Kyowa PD Site

Rome, , Italy

Kyowa PD Site

Venezia, , Italy

Kyowa PD Site

Vicenza, , Italy

Kyowa PD Site

Bydgoszcz, , Poland

Kyowa PD Site

Krakow, , Poland

Kyowa PD Site

Lublin, , Poland

Kyowa PD Site

Poznan, , Poland

Kyowa PD Site

Warsaw, , Poland

Kyowa PD Site

Warsaw, , Poland

Kyowa PD Site 1

Belgrade, , Serbia

Kyowa PD Site 4

Belgrade, , Serbia

Kyowa PD Site

Novi Sad, , Serbia

Countries

United States; Canada; Czechia; Germany; Israel; Italy; Poland; Serbia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

6002-018

Identifier Type: -

Identifier Source: org_study_id