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

NCT02610231 | Completed Phase 3 Results

• 1 other identifier: 6002-018
• Study Type: interventional
• Target: 239
• Locations: 8 countries
• Sites: 55

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

Keywords

Parkinson's disease; Moderate to Severe Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Long-term Safety and Tolerability of Oral Istradefylline (20mg or 40mg/Day [mg/d])

  The number of subjects experiencing an adverse event as well as clinical laboratory tests (chemistry, haematology and urinalysis) were collected to evaluate the safety profile of istradefylline (20mg or 40mg/day \[mg/d\]).

  From screening through to study completion, an average of 52 weeks

Secondary Outcomes (1)

• Patient Global Impression - Overall Condition (Improvement by Study Visit) (ITT Analysis Set).

  From baseline through to study completion at week 52, plus 30 days post last dose

Study Arms (1)

Istradefylline 20 mg or 40 mg

EXPERIMENTAL

Treatment for 52 weeks

Drug: Istradefylline 20 mg or 40 mg

Interventions

Istradefylline 20 mg or 40 mg DRUG

Istradefylline 20 or 40 mg

Also known as: KW-6002

Istradefylline 20 mg or 40 mg

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period;
• 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 and have a negative serum pregnancy test at Screening;

You may not qualify if:

• Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion;
• Subject who have had neurosurgical operation for PD;
• Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers;
• 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).

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Kyowa Hakko Kirin Pharma, Inc.: collaborator

Study Sites (55)

Kyowa PD Site

Phoenix, Arizona, 85004, United States

Location

Kyowa PD Site

Sun City, Arizona, 85351, United States

Location

Kyowa PD Site

Tucson, Arizona, 85724, United States

Location

Kyowa PD Site

Fountain Valley, California, 92708, United States

Location

Kyowa PD Site

Los Angeles, California, 90048, United States

Location

Kyowa PD Site

Oxnard, California, 93030, United States

Location

Kyowa PD Site

Torrance, California, 90505, United States

Location

Kyowa PD Site

Englewood, Colorado, 80113, United States

Location

Kyowa PD Site

Danbury, Connecticut, 06810, United States

Location

Kyowa PD Site

Boca Raton, Florida, 33486, United States

Location

Kyowa PD Site

Port Charlotte, Florida, 33952, United States

Location

Kyowa PD Site

Tampa, Florida, 33647, United States

Location

Kyowa PD Site

Atlanta, Georgia, 30329, United States

Location

Kyowa PD Site

Augusta, Georgia, 29841, United States

Location

Kyowa PD Site

Des Moines, Iowa, 50309, United States

Location

Kyowa PD Site

Kansas City, Kansas, 66160, United States

Location

Kyowa PD Site

Boston, Massachusetts, 02215, United States

Location

Kyowa PD Site

West Bloomfield, Michigan, 48322, United States

Location

Kyowa PD Site

Albany, New York, 12208, United States

Location

Kyowa PD Site

New York, New York, 10016, United States

Location

Kyowa PD Site

Asheville, North Carolina, 28806, United States

Location

Kyowa PD Site

Durham, North Carolina, 27705, United States

Location

Kyowa PD Site

Toledo, Ohio, 43614, United States

Location

Kyowa PD Site

Calgary, Alberta, T2N 4Z6, Canada

Location

Kyowa PD Site

Toronto, Ontario, M5T 2S8, Canada

Location

Kwoya PD Site

Brno, 602 00, Czechia

Location

Kyowa PD Site

Litomyšl, 570 01, Czechia

Location

Kyowa PD Site

Prague, 120 00, Czechia

Location

Kyowa PD Site

Prague, 140 00, Czechia

Location

Kyowa PD Site

Beelitz-Heilstätten, 14547, Germany

Location

Kyowa PD Site

Bremerhaven, 27574, Germany

Location

Kyowa PD Site

Dresden, 01307, Germany

Location

Kyowa PD Site

Haag, 83527, Germany

Location

Kyowa PD Site

Kassel, 34128, Germany

Location

Kyowa PD Site

München, 80804, Germany

Location

Kyowa PD Site

Haifa, 39106, Israel

Location

Kyowa PD Site

Jerusalem, 91120, Israel

Location

Kyowa PD Site

Ramat Gan, 52621, Israel

Location

Kyowa PD Site

Tel Aviv, 64239, Israel

Location

Kyowa PD Site

Grosseto, 58100, Italy

Location

Kyowa PD Site

Pavia, 27100, Italy

Location

Kyowa PD Site

Pisa, 56126, Italy

Location

Kyowa PD Site

Roma, 00133, Italy

Location

Kyowa PD Site

Rome, 00163, Italy

Location

Kyowa PD Site

Venezia, 30126, Italy

Location

Kyowa PD Site

Vicenza, 36057, Italy

Location

Kyowa PD Site

Bydgoszcz, 85-796, Poland

Location

Kyowa PD Site

Krakow, 31-505, Poland

Location

Kyowa PD Site

Lublin, 20-064, Poland

Location

Kyowa PD Site

Poznan, 61-853, Poland

Location

Kyowa PD Site

Warsaw, 01-697, Poland

Location

Kyowa PD Site

Warsaw, 04-364, Poland

Location

Kyowa PD Site 1

Belgrade, 11000, Serbia

Location

Kyowa PD Site 4

Belgrade, 11000, Serbia

Location

Kyowa PD Site

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Development Devision - Project Management Department
• Organization: Kyowa Kirin

kkd.clintrial.82@kyowakirin.com

609-919-1100

Study Officials

• Kyowa Hakko Kirin Pharma, Inc.

  Kyowa Hakko Kirin Pharma, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2015
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: April 25, 2024
• Results First Posted: December 13, 2019

Record last verified: 2024-04

Locations

CA (2); IT (7); DE (6); PL (6); SE (3); US (23); IL (4); CZ (4)