A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients

Phase 2

Completed

• Conditions: Parkinson's Disease; Movement Disorder Syndrome

• Registration Number: NCT00199433
• Lead Sponsor: Kyowa Kirin, Inc.

Brief Summary

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

Detailed Description

Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease.

This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2006-07
• Study Completion: 2006-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Early PD by UKPDS criteria
2. Mild to moderate difficulty daily activities
3. Females: Either postmenopausal or willing to use adequate contraception

Exclusion Criteria

1. Unable to discontinue current PD medication
2. Exposure to Levodopa for more than 1 month
3. Symptoms that may suggest a diagnosis other than Parkinson's disease
4. Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in the UPDRS subscale III at endpoint.

Secondary Outcome Measures

Name	Time	Method
Exam
Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
ECG
weight
laboratory tests and adverse events
vitals
Safety:

Trial Locations

Locations (1)

Kyowa Pharmaceutical Inc.; 🇺🇸 Princeton, New Jersey, United States