A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00455507

Collaborator

(none)

363

Enrollment

Location

Arms

17.1

Duration (Months)

21.3

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Istradefylline Drug: Istradefylline Drug: Placebo	Phase 2

Detailed Description

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 40mg/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.

Study Design

Study Type:

Interventional

Actual Enrollment :

363 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 2 Study)

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)	Drug: Istradefylline Two 10 mg KW-6002 tablets orally once daily for 12 weeks Other Names: KW-6002
Experimental: 2 40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks)	Drug: Istradefylline Two 20 mg tablets orally once a day for 12 weeks Other Names: KW-6002
Placebo Comparator: 3 Two placebo tablets once daily for 12 weeks	Drug: Placebo Two placebo tablets orally once daily for 12 weeks

Arm

Intervention/Treatment

Experimental: 1

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

Drug: Istradefylline

Two 10 mg KW-6002 tablets orally once daily for 12 weeks

Other Names:

KW-6002

Experimental: 2

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

Drug: Istradefylline

Two 20 mg tablets orally once a day for 12 weeks

Other Names:

KW-6002

Placebo Comparator: 3

Two placebo tablets once daily for 12 weeks

Drug: Placebo

Two placebo tablets orally once daily for 12 weeks

Outcome Measures

Primary Outcome Measures

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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor. [Last Visit]

Secondary Outcome Measures

To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state. [Every Visit]
To evaluate 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). [Every Visit]
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS). [Every Visit]
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). [Visit 4 and Last Visit]
To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline [Every Visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 >=300mg of levodopa 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.
Be at least 20 years of age.
Be willing and able to give written informed consent.