UMIN-CTR Clinical Trial

Basic information
Public title	Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.
Acronym	ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline)
Scientific Title	Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.
Scientific Title:Acronym	ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline)
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate whether the addition of istradefylline delays the onset of dyskinesia in Parkinson's disease patients experiencing wearing-off symptoms on levodopa therapy but who have never experienced dyskinesia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Time to onset of dyskinesia
Key secondary outcomes	-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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2	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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion 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.
Key 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.
Target sample size	280

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Tsuboi
Organization	Fukuoka University
Division name	Neurology
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, JAPAN
TEL	092-801-1011
Email	tsuboi@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Yoshio Middle name Last name Tsuboi
Organization	Fukuoka University
Division name	Neurology
Zip code	814-0180
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, JAPAN
TEL	092-801-1011
Homepage URL
Email	odyssei@kyowa-kirin.co.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka University Medical Ethics Review Board
Address	8-19-1 Nanakuma, Jonan-ku, Fukuoka
Tel	092-801-1011
Email	odyssei@kyowa-kirin.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs071180014
Org. issuing International ID_1	jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	214
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 11 Month 02 Day
Anticipated trial start date	2016 Year 11 Month 28 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 24 Day
Last modified on	2019 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028214