Movement Disorder Syndrome, Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, Movement Disorder, Neurology,, Clinical Trial
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.
Interventions
Sponsors
Kyowa Kirin Co., Ltd.
Kyowa Kirin, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the UPDRS subscale III at endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: | — |
| Exam | — |
| vitals | — |
| Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing. | — |
| ECG | — |
| laboratory tests and adverse events | — |
| weight | — |
Countries
United States
Outcome results
None listed