Clinical trial

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

NCT00199433

Name

6002-US-051

Description

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.

Trial arms

Trial start

2005-05-01

Estimated PCD

2006-07-01

Trial end

2006-08-01

Status

Completed

Phase

Early phase I

Treatment

Istradefylline (KW-6002)

Size

160

Primary endpoint

Change from baseline in the UPDRS subscale III at endpoint.

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 160}}

Updated at

2024-04-25

1 organization

1 product

2 indications

Organization

Product

Indication

Indication