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

• Sponsor: Kyowa Kirin, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00199433
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 10.7

Study Details

Study Description

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.

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

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

1. Change from baseline in the UPDRS subscale III at endpoint. []

Secondary Outcome Measures

1. Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing. []

2. Safety: []

3. Exam []

4. vitals []

5. weight []

6. ECG []

7. laboratory tests and adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyowa Pharmaceutical Inc.	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• Kyowa Kirin, Inc.

Investigators

• Study Director: Neil Sussman, MD, Kyowa Kirin, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00199433
• Other Study ID Numbers: 6002-US-051
• First Posted: Sep 20, 2005
• Last Update Posted: Jul 13, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by , ,: Parkinson's Disease; Movement Disorder; Neurology,; Clinical Trial
• Additional relevant MeSH terms: Parkinson Disease; Movement Disorders; Istradefylline

Study Results

No Results Posted as of Jul 13, 2016