A 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

NCT00199355

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Istradefylline (KW-6002)	Phase 2

Detailed Description

To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time 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/d 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

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI. []

Secondary Outcome Measures

To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time. []
To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia). []
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS). []
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). []
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S). []
To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 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/DCI for at least one year, stable dose in past 4 weeks.
Currently take at least three doses of levodopa/DCI per day.
Predictable end of dose wearing off.
Able to satisfactorily complete Hauser version of a Parkinson's diary.
Have an average of 120 minutes of OFF time on two 24 hour diaries.
On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
Be at least 30 years of age.