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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024536
Receipt No. R000028214
Scientific Title Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.
Date of disclosure of the study information 2016/10/25
Last modified on 2019/07/05

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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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028214

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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