Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000024536
• Date of registration: 25/10/2016
• Prospective Registration: Yes
• Primary sponsor: Fukuoka University
• Public title: Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.
• Scientific title: Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline)
• Date of first enrolment: 2016/11/28
• Target sample size: 280
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028214
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Yoshio Tsuboi
• Affiliation: Fukuoka University Neurology

• Name: Yoshio Tsuboi
• Affiliation: Fukuoka University Neurology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: (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.

Age minimum: 30years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Parkinson's disease

Intervention(s)

Treatment with istradefylline combined with optimal medical therapy. 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 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including istradefylline will be applied to each patient.
Optimal medical therapy without istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without istradefylline will be applied to each patient.

Primary Outcome(s)

Time to onset of dyskinesia

Secondary Outcome(s)

-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

Secondary ID(s)

jRCTs071180014

Source(s) of Monetary Support

Kyowa Hakko Kirin Co., Ltd.

Ethics review

Status: YES
Approval date: 02/11/2016
Contact:

[e-mail]

Fukuoka University Medical Ethics Review Board

092-801-1011

[e-mail]

Results

• Results available: Yes
• Date Completed: 31/05/2022