6002-009: Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00955526

Collaborator

(none)

373

Enrollment

Location

Arms

19.1

Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Istradefylline Drug: Istradefylline Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

373 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Istradefylline 20mg	Drug: Istradefylline 20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks) Other Names: KW-6002
Experimental: Istradefylline 40mg	Drug: Istradefylline 40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks) Other Names: KW-6002
Placebo Comparator: Placebo	Drug: Placebo Two placebo tablets once daily for 12 weeks

Arm

Intervention/Treatment

Experimental: Istradefylline 20mg

Drug: Istradefylline

20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)

Other Names:

KW-6002

Experimental: Istradefylline 40mg

Drug: Istradefylline

40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks)

Other Names:

KW-6002

Placebo Comparator: Placebo

Drug: Placebo

Two placebo tablets once daily for 12 weeks

Outcome Measures

Primary Outcome Measures

Reducing the mean total hours of awake time per day spent in the OFF state []

Secondary Outcome Measures

Reducing the mean percentage of awake time per day spent in the OFF state []
Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia) []
Change in Unified Parkinson's Disease Rating Scale (UPDRS) []
Change in the Clinical Global Impression - Improvement scale (CGI-I) []
Adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be willing and able to give written informed consent
UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
On levodopa/dopa-decarboxylase inhibitor for at least one year
Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
Predictable end of dose wearing off
Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
Have an average of two hours of OFF time on 24-hour diaries
On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
On a stable dose of domperidone for at least 14 days before randomization