UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062668 |
|---|---|
| Receipt number | R000071633 |
| Scientific Title | REAL-WORLD EFFECTIVENESS OF BRIVARACETAM INITIAL MONOTHERAPY IN NEWLY DIAGNOSED ADULT PATIENTS WITH FOCAL ONSET SEIZURES IN JAPAN |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/24 14:49:10 |
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Basic information
Public title
Effectiveness of Brivaracetam Used as the First Anti-Seizure Medication in Routine Clinical Practice for Japanese Patients with Epilepsy
Acronym
BRIVA-Mono
Scientific Title
REAL-WORLD EFFECTIVENESS OF BRIVARACETAM INITIAL MONOTHERAPY IN NEWLY DIAGNOSED ADULT PATIENTS WITH FOCAL ONSET SEIZURES IN JAPAN
Scientific Title:Acronym
BRIVA-Mono
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of brivaracetam initial monotherapy in adult patients with focal onset (partial onset) seizures after brivaracetam treatment initiation for at least 12 months.
Basic objectives2
Others
Basic objectives -Others
effectiveness
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient with continuous seizure freedom (all seizure types) for at least 12 consecutive months during the brivaracetam monotherapy observation period
Key secondary outcomes
-Patient with continuous seizure freedom (all seizure types) for at least 6 consecutive months during the brivaracetam monotherapy observation period
-Brivaracetam retention at 1, 3, 6, 12, 18, and 24 months
-Treatment-emergent adverse events (TEAEs) (overall; serious; drug related; behavioral, leading to discontinuation of brivaracetam)
-Neuropsychiatric TEAEs
-Adverse events of special interest (AESIs)
-Other safety relevant information
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 has never received treatment with any antiseizure medication for any indication. The short acute use of rescue medication for seizure treatment is allowed. Any prior treatment with brivaracetam before brivaracetam initiation at study entry is not allowed.
2.The patient is 18 years of age or older at the timing of signing the Patient Data Consent Form (PDCF).
3.The patient has a confirmed clinical history of focal onset seizures and has had at least 1 focal onset seizures (focal aware, focal with impaired awareness, or focal to bilateral tonic-clonic seizures) during the past 6 months prior to baseline.
4.A PDCF is signed and dated by the patient.
5.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 24-month period.
6.The decision by the treating physician to prescribe brivaracetam tablets as initial monotherapy must be made independent from participation in the non-interventional study and is in line with the drug's 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
独立行政法人 国立病院機構静岡てんかん・神経医療センター（静岡県）/NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 25 | 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 | 03 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 02 | Month | 14 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071633
