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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047791
Receipt No. 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 2022/05/18

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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
Institute INTAGE Healthcare Inc.
Institute
Department

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 Preinitiation
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 06 Month 01 Day
Last follow-up date
2022 Year 06 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
2022 Year 05 Month 18 Day


Link to view the page
URL(English) 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


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