UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063262 |
|---|---|
| Receipt number | R000072414 |
| Scientific Title | REAL-WORLD OUTCOMES IN EPILEPSY PATIENTS WHO TRANSITIONED FROM LEVETIRACETAM MONOTHERAPY TO BRIVARACETAM MONOTHERAPY DUE TO INTOLERABLE ADVERSE DRUG REACTIONS: A PROSPECTIVE, NON-INTERVENTIONAL STUDY IN JAPAN |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/13 22:18:54 |
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Basic information
Public title
A Prospective Observational Study Evaluating Outcomes in Patients with Epilepsy Switched from Levetiracetam Monotherapy to Brivaracetam Monotherapy Due to Adverse Drug Reaction
Acronym
BRIVA-Switch
Scientific Title
REAL-WORLD OUTCOMES IN EPILEPSY PATIENTS WHO TRANSITIONED FROM LEVETIRACETAM MONOTHERAPY TO BRIVARACETAM MONOTHERAPY DUE TO INTOLERABLE ADVERSE DRUG REACTIONS: A PROSPECTIVE, NON-INTERVENTIONAL STUDY IN JAPAN
Scientific Title:Acronym
BRIVA-Switch
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change from baseline at 12W in severity of adverse drug reactions to levetiracetam in patients who transitioned to brivaracetam monotherapy after discontinuation of levetiracetam monotherapy due to occurrence of adverse drug reactions
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse drug reactions to levetiracetam with an improvement in severity (resolved, mild, moderate, severe) compared to baseline after 12W treatment with brivaracetam
Key secondary outcomes
-Adverse drug reactions to levetiracetam with an improvement in severity (resolved, mild, moderate, severe) compared to baseline after 4W and 8W treatment with brivaracetam
-Adverse drug reactions to levetiracetam with a worsening in severity (mild, moderate, severe) compared to baseline after 4W, 8W, and 12W treatment with brivaracetam
-Adverse drug reactions to levetiracetam with no change in severity (mild, moderate, severe) compared to baseline after 4W, 8W, and 12W treatment with brivaracetam
-Behavioral adverse drug reactions to levetiracetam with an improvement in severity (resolved, mild, moderate, severe) compared to baseline after 4W, 8W, and 12W treatment with brivaracetam
-Behavioral adverse drug reactions to levetiracetam with a worsening in severity (mild, moderate, severe) compared to baseline after 4W, 8W, and 12W treatment with brivaracetam
-Behavioral adverse drug reactions to levetiracetam with no change in severity (mild, moderate, severe) compared to baseline after 4W, 8W, and 12W treatment with brivaracetam
-Patient with a shift in maximum severity (mild, moderate and severe) of any adverse drug reactions to levetiracetam at baseline to maximum severity (resolved, mild, moderate and severe) after 4W, 8W, and 12W treatment with brivaracetam
-Patient with a shift in maximum severity (mild, moderate and severe) of behavioral adverse drug reactions to levetiracetam at baseline to maximum severity (resolved, mild, moderate and severe) after 4W, 8W, and 12W treatment with brivaracetam
-Treatment-emergent adverse events (overall and by time of occurrence; serious; drug related; behavioral, leading to discontinuation of brivaracetam) at 4W, 8W, and 12W
-Adverse event of special interests
-Other safety relevant information
-Seizure freedom (all seizure types) from baseline to 4W, 8W, and 12W
-Brivaracetam retention at 4W, 8W, and 12W
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
1.The patient is 18 years of age or older at the time of signing the Patient Data Consent Form (PDCF).
2.The patient has a confirmed clinical history of focal onset seizures with or without focal to bilateral tonic-clonic seizures.
3.The patient has never been treated with brivaracetam before.
4.The patient has been receiving levetiracetam monotherapy prior to baseline and must discontinue levetiracetam treatment due to intolerable adverse drug reactions.
5.A PDCF is signed and dated by the patient.
6.The patient is considered by the treating physician to be reliable and capable of adhering to the protocol and is willing to be followed for a 12 weeks period.
7.The decision by the treating physician to prescribe brivaracetam is made independent from participation in the non-interventional study and in line with the drug license and the (local) summary of product characteristics.
Key exclusion criteria
NA
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
UCB Japan Co. Ltd.
Division name
Medical Affairs Division, Epilepsy Medical Affairs Department
Zip code
160-0023
Address
Shinjuku Grand Tower, 8-17-1 Nishi-Shinjuku, Shinjuku-ku
TEL
03-6864-8664
jun.watanabe@ucb.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
UCB Japan Co. Ltd.
Division name
Medical Affairs Division, Epilepsy Medical Affairs Department
Zip code
160-0023
Address
Shinjuku Grand Tower, 8-17-1 Nishi-Shinjuku, Shinjuku-ku
TEL
03-6864-8664
Homepage URL
jun.watanabe@ucb.com
Sponsor or person
Institute
UCB Biopharma SRL
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Belgium
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Research Ethics Committee
Address
Mita 5-20-9-401,Minato-ku,Tokyo
Tel
03-6416-1868
npo-mins@j-irb.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
愛知医科大学病院（愛知県）/Aichi Medical University Hospital (Aichi)
医療法人福智会 すずかけクリニック（愛知県）/Suzukake Clinic (Aichi)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 15 | 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
| 2026 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2028 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 08 | Month | 04 | Day |
Date analysis concluded
| 2028 | Year | 09 | Month | 04 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2026 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072414
