A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 7/14/2016 |
| Start Date: | May 2005 |
| End Date: | August 2006 |
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
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.
40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's
disease.
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.
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.
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
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