UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012755
Receipt number R000014904
Scientific Title Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke
Date of disclosure of the study information 2014/01/04
Last modified on 2015/03/03 17:31:03

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Basic information

Public title

Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke

Acronym

Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke

Scientific Title

Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke

Scientific Title:Acronym

Efficacy of ramelteon on sleep disturbance and restlessness in acute stroke

Region

Japan


Condition

Condition

stroke

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We intend for the patients with sleep disturbance in acute stroke and assess the effect of ramelteon on sleep disturbance and restlessness by controlling the sleep-wake cycle.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Richmond agitation sedation scale two weeks after intervention

Key secondary outcomes

sleep condition/ insomnia/ daytime somnolence/ administration of sedative medication, psychotropic medication and sleep medication except for ramelteon/ body restraint/ fall/ modified Rankin Scale/ adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration group:ramelteon 8mg, just before sleep, daily

Interventions/Control_2

Non-administration group

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who were hospitalized for a stroke acute phase and experienced sleep disruption

Key exclusion criteria

1.Patients taking ramelteon at the time of admission
2.Patients with contraindication for ramelteon (known hypersensitivity to remelteon, a history of severe liver/hepatic dysfunction, patients taking fluvoxamine maleate)
3.Patients who were not able to take drug both orally and through the tube

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Kawabata

Organization

Yokohama Sakae Kyosai Hospital

Division name

Department of Neurology and Stroke Medicine

Zip code


Address

132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa, Japan

TEL

045-891-2171

Email

y-kawabat@hotmail.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Kawabata

Organization

Yokohama Sakae Kyosai Hospital

Division name

Department of Neurology and Stroke Medicine

Zip code


Address

132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa, Japan

TEL

045-891-2171

Homepage URL


Email

y-kawabat@hotmail.co.jp


Sponsor or person

Institute

Yokohama Sakae Kyosai Hospital

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


Address


Tel


Email



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

横浜栄共済病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 04 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


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

Completed

Date of protocol fixation

2013 Year 12 Month 11 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 04 Day

Last modified on

2015 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name