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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023891
Receipt No. 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

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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
Email 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
Email masashir@gipc.akita-u.ac.jp

Sponsor
Institute Akita University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027253

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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