UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047531 |
|---|---|
| Receipt number | R000054202 |
| Scientific Title | The Burden of Illness of Rare Epilepsies (Dravet syndrome, Lennox-Gastaut and Tuberous Sclerosis Complex) in Caregivers in Japan: An Emotional Journey Study |
| Date of disclosure of the study information | 2022/04/21 |
| Last modified on | 2023/05/31 16:00:33 |
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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: An Emotional Journey 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: An Emotional Journey 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). In particular, the impact of the condition on the emotional state of caregivers throughout the course of the condition from onset of symptoms to their present state following initiation of treatment will be clarified.
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
The impact of three rare epilepsy conditions on caregivers as reported qualitatively by physicians and 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
[Physicians]
Physician participants must meet ALL of the following criteria to be considered for enrollment:
.A licensed and practicing physicians in Japan
.3 or more year of experience in practice
.Pediatrician or neurologist
.Treating 3 or more patients in total among the three conditions (DS, LGS, and/or TSC) that are being treated for epilepsy symptoms
Supplemental: Includes patients who are not currently experiencing epilepsy symptoms due to epilepsy treatment.
[Caregivers]
Caregiver 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
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
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 Takakise-machi Nagase, Saga City, Saga Prefecture
Tel
0952-31-7771
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 | 04 | Month | 21 | 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 | 02 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 20 | 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 : Qualitative interviews lasting 60 minutes with a pre-interview worksheet exercise lasting 15-30 minutes
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054202
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| Registered date | File name |
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| Registered date | File name |
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