Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.
- Conditions
- s diseaseParkinson'
- Registration Number
- JPRN-UMIN000024536
- Lead Sponsor
- Fukuoka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 214
Not provided
(1)Current use of istradefylline (within 1 year prior to study entry) (2)Current use of amantadine (within 3 months prior to study entry) (3)Current use of an investigational drug (within 4 months prior to study entry.) (4)Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE) (5)Patients with a previous history of brain surgery for the treatment of parkinson's disease. (6)Current use or plan to administer levodopa/carbidopa intestinal gel (7)Patients with moderate to severe hepatic disorder (8)Current use of a strong inhibitor of CYP3A4 (within 14days prior to study entry) (9)Current use of typical and atypical antipsychotics (within 3 months prior to study entry) (10)Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant. (11)Patients who are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to onset of dyskinesia
- Secondary Outcome Measures
Name Time Method -Time to onset of troublesome dyskinesia -Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part1,2,3,4 score and total score -Change in Parkinson's Disease Questionnaire (PDQ)-39 score -Change in modifyied Hoehn & Yahr scale -Change in Mini Mental State Examination (MMSE) score -Change in Levodopa dose and Levodopa equivalent dose