UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019676 |
|---|---|
| Receipt number | R000022737 |
| Scientific Title | The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2019/03/25 13:28:21 |
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Basic information
Public title
The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease
Acronym
The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease
Scientific Title
The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease
Scientific Title:Acronym
The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our purpose of this trial is to assess whether modafinil improve excessive daytime sleepiness in Parkinson's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of the Epworth Sleepiness Scale score
Key secondary outcomes
change of UPDRS part2 and 3 score, Mini Mental State Examination score, basic rhythm of brain waves and evaluation of caregivers
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
taking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks
Interventions/Control_2
taking matching placebo after breakfast for 4 weeks, wash out for 2 weeks, taking modafinil (200 mg/day) after breakfast for 4 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1: Patients with parkinson' disease
2: ESS total score >=8
Key exclusion criteria
1 : Patient who can not take orally.
2 : Patient with severe arrhythmia.
3 : Pregnant women and lactating patient
4 : Patient can not answer a questionnaire about excessive daytime sleepiness.
5 : Patient can not make regular clinic visits.
6 : Patient have methylphenidate or/and Pemoline.
7 : Patient is difficult to express one's agreement.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Rina |
| Middle name | |
| Last name | Ando |
Organization
Ehime University Graduate School of Medicine
Division name
Neurology and Clinical Pharmacology
Zip code
791-0295
Address
Tohon, Ehime 791-0295, Japan
TEL
089-960-5095
ando.rina.cn@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Rina |
| Middle name | |
| Last name | Ando |
Organization
Ehime University Graduate School of Medicine
Division name
Neurology and Clinical Pharmacology
Zip code
791-0295
Address
Tohon, Ehime 791-0295, Japan
TEL
089-960-5095
Homepage URL
ando.rina.cn@ehime-u.ac.jp
Sponsor or person
Institute
Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board ,Ehime University Hospital
Address
Tohon, Ehime, Japan
Tel
089-960-5914
rinri@m.ehime-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 10 | 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
14
Results
There were no significant differences in ESS scores, daytime hypersomnia assessment by companion questionnaire, MMSE, and UPDRS part 3 between modiodal and placebo groups.
Results date posted
| 2019 | Year | 03 | Month | 25 | Day |
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 07 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022737
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| Registered date | File name |
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