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A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Sponsor
UCB Biopharma SRL (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04715646
Collaborator
(none)
70
Enrollment
26
Locations
1
Arm
52.2
Anticipated Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 [NCG03325439] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 [NCT01364597]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
Actual Study Start Date :
Mar 11, 2021
Anticipated Primary Completion Date :
Jul 17, 2025
Anticipated Study Completion Date :
Jul 17, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brivaracetam

LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day.

Drug: Brivaracetam
Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral
Other Names:
  • BRV
  • Briviact

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events (TEAEs) during the study [From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)]

      An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.

    2. Incidence of treatment-emergent serious adverse events (SAEs) during the study [From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)]

      A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly or birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

    3. Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study [From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)]

      An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Inclusion criteria for long-term follow-up (LTFU) study participants only

    • Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439]

    Inclusion criteria for directly enrolled (DE) study participants in Japan only

    • Study participant is ≥ 4 years to < 16 years of age

    • Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years

    • Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)

    • Study participant had at least 1 POS during the 4-week Screening Period

    Exclusion Criteria:

    Exclusion criteria for all study participants

    • Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant

    • Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).

    Exclusion criteria for long-term follow-up (LTFU) study participants only

    • Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)

    Exclusion criteria for directly enrolled (DE) study participants in Japan only

    • Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures

    • Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period

    • Study participant has any clinically significant illness

    • Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results

    • Study participant has a clinically significant ECG abnormality

    • Study participant had major surgery within 6 months prior to the ScrV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ep0156 259 Hawthorne New York United States 10532
    2 Ep0156 237 Durham North Carolina United States 27710
    3 Ep0156 210 Budapest Hungary
    4 Ep0156 247 Budapest Hungary
    5 Ep0156 232 Miskolc Hungary
    6 Ep0156 230 Roma Italy
    7 Ep0156 803 Bunkyo-ku Japan
    8 Ep0156 808 Chuo Japan
    9 Ep0156 800 Gifu-City Japan
    10 Ep0156 807 Hiroshima Japan
    11 Ep0156 813 Koshi Japan
    12 Ep0156 806 Kyoto Japan
    13 Ep0156 811 Nagoya-city Japan
    14 Ep0156 812 Niigata-city Japan
    15 Ep0156 805 Sapporo-city Japan
    16 Ep0156 809 Shimotsuke Japan
    17 Ep0156 804 Tokyo Japan
    18 Ep0156 810 Yokohama Japan
    19 Ep0156 802 Yonago Japan
    20 Ep0156 223 Aguascalientes Mexico
    21 Ep0156 609 Culiacan Mexico
    22 Ep0156 603 Guadalajara Mexico
    23 Ep0156 406 Kielce Poland
    24 Ep0156 402 Krakow Poland
    25 Ep0156 401 Poznan Poland
    26 Ep0156 248 Sevilla Spain

    Sponsors and Collaborators

    • UCB Biopharma SRL

    Investigators

    • Study Director: UCB Cares, 001 844 599 2273 (UCB)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UCB Biopharma SRL
    ClinicalTrials.gov Identifier:
    NCT04715646
    Other Study ID Numbers:
    • EP0156
    • 2020-003664-29
    First Posted:
    Jan 20, 2021
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by UCB Biopharma SRL
    Epilepsy
    Brivaracetam
    Pediatric
    Child
    Additional relevant MeSH terms:
    Epilepsy
    Brivaracetam

    Study Results

    No Results Posted as of Jul 8, 2022