ODYSSEI Study

JRCT ID: jRCTs071180014

Registered date:29/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 08/03/2017
• Target sample size: 280
• Countries of recruitment: N A,Japan
• Study type: Interventional

Intervention(s)

Arm A: 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.

Arm B: 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.

Outcome(s)

• Primary Outcome: Time to onset of dyskinesia

Secondary Outcome

-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 modified Hoehn & Yahr scale
-Change in Mini Mental State Examination (MMSE) score
-Change in Levodopa dose and Levodopa equivalent dose

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1)Current use of levodopa-containing drugs more than 300mg/day administered at least three times daily
2)Patients with wearing-off
3)Patients who have never previously experienced dyskinesia
4)>= 30 to < 80 years of age at the time of consent.
5)Diagnosed as Parkinson's disease based on UK Parkinson's Disease Society Brain Bank criteria
6)Stages <=4 in the ON state for Modified Hoehn and Yahr Scale.
7)Stable antiparkinson drug regimen for at least 4 weeks prior to study entry.
8)Completion of patient diary training and able to satisfactorily complete patient diary.
9)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

Exclude 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.

Related Information

• Primary Sponsor: Tsuboi Yoshio
• Secondary Sponsor: Kyowa Kirin Co., Ltd.
• Secondary ID(s): UMIN000024536