Parkinson's disease
Conditions
Interventions
Arm with treatment of Istradefylline and levodopa
Treatment with Istradefylline will be started at a dose of
20 mg administered once daily at Week 0. The dose of
Istradefylline will be increased to 40
Sponsors
Hatano Taku
Kyowa Kirin Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Current use of levodopa-containing drugs more than 300mg/day and less than 400mg/day administered at least three times daily 2) Patients with wearing-off 3) >= 30 to < 85 years of age at the time of registration for the study 4) Diagnosed as Parkinson's disease based on the International Parkinson and Movement Disorder Society (MDS) 5) Stages <=3 in the ON state for Modified Hoehn and Yahr Scale 6) Patients who have given written consent if the patient has difficulty in writing due to his or her condition, a representative may sign the written consent, subject to the patient's prior oral consent
Exclusion criteria
Exclusion criteria: 1) Use of Istradefylline in the past 2) Current use of an investigational drug (within 4 months prior to the registration for the study) 3) Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE) 4) Patients with a previous history of brain surgery for the treatment of Parkinson's disease at the time point of the registration 5) Current use or plan to administer levodopa/carbidopa intestinal gel at the time point of the registration 6) Patients with moderate to severe hepatic disorder 7)Use of a new anti-Parkinson's disease drugs or change in the treatment of anti-Parkinson's disease drugs within 14 days prior to the registration for the study 8) Current use of a strong inhibitor of CYP3A4 (Itraconazole, Clarithromycin) within 14days prior to the registration of the study 9) Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant 10) Patients who are in the Investigator's judgment unlikely to comply with medical regimens or study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accumulated dose of Levodopa | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional dose of every time points after Week4 until Week36 Number of the days to the first additional dose from Week0 Change in the dose of levodopa until Week36 CGS-S score and change in CGS-S CGS-I score from the previous visit PGS-S score and change in PGS-S PGS-I score from the previous visit Change in modified Hoehn & Yahr scale Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part1,2,3,4 score and total score 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 Correlation among the score change presented Analysis of the motion (frequency, strength), gait(counts,pitch, balance), sleeping (bedtime, Wake-up time, time of sleeping, sleep efficiency, sleep onset latency, frequency and intensity of physical activity during sleep, total time of bed-leaving, REM/Non-REM) using wearable device | — |
Contacts
Public ContactYoshiyuki Matsuzaki
Mebix Co., Ltd.
Outcome results
None listed