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

Parkinson's Disease Clinical Trial

Official title:

A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199433
• Other study ID #: 6002-US-051
• Status: Completed
• Phase: Phase 2
• Start date: May 2005
• Est. completion date: August 2006

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorder Syndrome
• Movement Disorders
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Istradefylline (KW-6002)

Locations

Country	Name	City	State
United States	Kyowa Pharmaceutical Inc.	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin, Inc.	Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the UPDRS subscale III at endpoint.
Secondary	Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.
Secondary	Safety:
Secondary	Exam
Secondary	vitals
Secondary	weight
Secondary	ECG
Secondary	laboratory tests and adverse events