UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024536 |
|---|---|
| Receipt number | 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 16:11:15 |
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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
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
odyssei@kyowa-kirin.co.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028214
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