UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023891 |
|---|---|
| Receipt number | R000027253 |
| Scientific Title | Consideration of the validity of ramelteon for Tourette's syndrome. |
| Date of disclosure of the study information | 2016/09/05 |
| Last modified on | 2019/03/15 08:55:16 |
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Basic information
Public title
Consideration of the validity of ramelteon for Tourette's syndrome.
Acronym
Consideration of the validity of ramelteon for Tourette's syndrome.
Scientific Title
Consideration of the validity of ramelteon for Tourette's syndrome.
Scientific Title:Acronym
Consideration of the validity of ramelteon for Tourette's syndrome.
Region
| Japan |
Condition
Condition
Tourette's syndrome
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of ramelteon for reduction of vocal and motor tic in the patients with Tourette's syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Efficacy; Yale Global Tic Severity Scale (0W, 2W, 6W, 8W)
Key secondary outcomes
Y-BOCS, GTS-QOL, pattern of sleep
Safety; Adverse events and adverse effects (vital sign, laboratory data)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
8 mg of ramelteon is added to preceding treatment before a sleep once a day. Administration period is 6 weeks.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 18-30 years of age
2) Patient who fills the diagnostic criteria of "Tourette's disorder" according to the DSM-V.
3) Patient who can declare the one's own written agreement to participate in the study.
Key exclusion criteria
1) Having a history of other neurological and psychiatric disorders that can affect the motor and psychological function.
2) Having a distinct focal lesion on the brain MRI.
3) Patient who had change in the treatment within 4 weeks prior to the registration.
4) Patient who had been medicated ramelteon in the past.
5) Having liver dysfunction.
6) Having severe sleep apnea syndrome.
7) Taking an administration of fluvoxamine maleate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masashiro |
| Middle name | |
| Last name | SUGAWARA |
Organization
Akita University Hospital
Division name
Dept. of Neurology
Zip code
0108543
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6104
masashir@gipc.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashiro |
| Middle name | |
| Last name | SUGAWARA |
Organization
Akita University Hospital
Division name
Dept. of Neurology
Zip code
0108543
Address
1-1-1 Hondo, Akita, Japan
TEL
018-884-6104
Homepage URL
masashir@gipc.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University Hospital
Address
44-2 Aza-Hasunuma Hiroomote Akita, Japan
Tel
018-884-6216
rinsho@hos.akita-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
秋田大学医学部附属病院（秋田県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 05 | 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
0
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 | 03 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027253
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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