UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047791
Receipt number R000054487
Scientific Title The Burden of Illness of Rare Epilepsies (Dravet syndrome, Lennox-Gastaut and Tuberous Sclerosis Complex) in Caregivers in Japan: A Caregiver Burden Study
Date of disclosure of the study information 2022/05/18
Last modified on 2023/05/31 15:56:59

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The Burden of Illness of Rare Epilepsies (Dravet syndrome, Lennox-Gastaut and Tuberous Sclerosis Complex) in Caregivers in Japan: A Caregiver Burden Study

Acronym

The Burden of Illness of Rare Epilepsy in Caregivers

Scientific Title

The Burden of Illness of Rare Epilepsies (Dravet syndrome, Lennox-Gastaut and Tuberous Sclerosis Complex) in Caregivers in Japan: A Caregiver Burden Study

Scientific Title:Acronym

The Burden of Illness of Rare Epilepsy in Caregivers

Region

Japan


Condition

Condition

Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex

Classification by specialty

Neurology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to assess and understand the impact of three rare epilepsy conditions on caregivers: Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC). To assess the impact of Dravet syndrome (DS), Lennox Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC) on the quality of life (QoL), economic burden, and productivity loss among caregivers of patients with rare epilepsy conditions.

Basic objectives2

Others

Basic objectives -Others

To assess and understand the impact of three rare epilepsy conditions on caregivers

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Burden of Caregivers of Three Rare Epilepsy Diseases Based on a Quantitative Questionnaire Survey of Caregivers

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Participants must meet ALL of the following criteria to be considered for enrollment:
.Aged 18 or older
.Born in and currently reside in Japan
.Caregivers of patients with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) or tuberous sclerosis syndrome (TSC)
.Caregivers of patients who have had a diagnosis of the disease for at least 12 months.
.Caregivers of patients currently receiving treatment for epilepsy symptoms
Supplemental:Includes patients who are not currently experiencing epilepsy symptoms due to epilepsy treatment.

Key exclusion criteria

Those who do not meet the inclusion criteria

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Michael
Middle name
Last name LOPRESTI

Organization

INTAGE Healthcare Inc.

Division name

Data Science Division

Zip code

101-0062

Address

Ochanomizu Sola City 13F 4-6 Kanda Surugadai Chiyoda-ku, Tokyo 101-0062, Japan

TEL

050-3640-1444

Email

m.lopresti@intage.com


Public contact

Name of contact person

1st name Michael
Middle name
Last name LOPRESTI

Organization

INTAGE Healthcare Inc.

Division name

Data Science Division

Zip code

101-0062

Address

Ochanomizu Sola City 13F 4-6 Kanda Surugadai Chiyoda-ku, Tokyo 101-0062, Japan

TEL

050-3640-1444

Homepage URL


Email

m.lopresti@intage.com


Sponsor or person

Institute

INTAGE Healthcare Inc.

Institute

Department

Personal name



Funding Source

Organization

GW Pharmaceutical, plc

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

United Kingdom


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keiaikai Medical Corporation Saga Memorial Hospital

Address

1240-1 Takagise-cho, Saga City, Saga Prefecture

Tel

0952-31-7771

Email

sagakinen8490917@gmail.com


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

2022 Year 05 Month 18 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

2022 Year 04 Month 04 Day

Date of IRB

2022 Year 04 Month 12 Day

Anticipated trial start date

2022 Year 09 Month 01 Day

Last follow-up date

2022 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Method: Online questionnaire survey


Management information

Registered date

2022 Year 05 Month 18 Day

Last modified on

2023 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054487


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name