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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05109234
Other study ID # EP0132
Secondary ID 2020-002769-33
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date March 30, 2022
Est. completion date September 27, 2024

Study information

Verified date June 2024
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 140
Est. completion date September 27, 2024
Est. primary completion date September 27, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years to 26 Years
Eligibility Inclusion Criteria: - Participants who previously participated in N01269 (NCT04666610) and qualify for entry into EP0132 as per N01269 (NCT04666610) protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected, in the opinion of the Investigator - A sexually active male study participant must agree to use contraception during the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period - A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: 1. The study participant is premenarchal OR 2. A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study medication, corresponding to the time needed to eliminate study treatment - Study participant is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: - Study participant has a history or presence of paroxysmal nonepileptic seizures - Study participant has severe medical, neurological, or psychiatric disorders or laboratory values, which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation - Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator - Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment - Study participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) or clinical judgment (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional - Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The Investigator must immediately refer the study participant to a Mental Healthcare Professional - Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study - Participant has a known fructose intolerance or known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. Note that the tablets contain lactose - Study participant has end-stage kidney disease requiring dialysis - Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin - Study participant has planned participation in any clinical study on an investigational drug or device - Study participant has poor compliance with the visit schedule or medication intake in the core study in the opinion of the Investigator

Study Design


Intervention

Drug:
Brivaracetam Film-coated tablet
Pharmaceutical form: Film-coated tablet Route of administration: Oral use Brivaracetam film-coated tablet [10, 25 or 50 mg] will be administered twice per day in equal doses.
Brivaracetam oral solution
Pharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution [10 mg/mL]) will be administered twice per day in equal doses.

Locations

Country Name City State
Georgia Ep0132 400 Tbilisi
Georgia Ep0132 401 Tbilisi
Georgia Ep0132 402 Tbilisi
Georgia Ep0132 403 Tbilisi
Georgia Ep0132 405 Tbilisi
Italy Ep0132 323 Messina
Italy Ep0132 321 Milano
Italy Ep0132 324 Milano
Italy Ep0132 320 Pavia
Italy Ep0132 322 Roma
Italy Ep0132 325 Roma
Italy Ep0132 326 Verona
Romania Ep0132 562 Bucuresti
Romania Ep0132 563 Bucuresti
Romania Ep0132 560 Iasi
Romania Ep0132 561 Timisoara, Judet Timis
Slovakia Ep0132 632 Bardejov
Slovakia Ep0132 630 Dubnica Nad Vahom
Spain Ep0132 354 Terrassa
Ukraine Ep0132 600 Dnipro
Ukraine Ep0132 601 Dnipro
Ukraine Ep0132 607 Uzhgorod
Ukraine Ep0132 602 Vinnytsia
United States Ep0132 110 Augusta Georgia
United States Ep0132 115 Birmingham Alabama
United States Ep0132 100 New Brunswick New Jersey
United States Ep0132 105 Orange California
United States Ep0132 109 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Georgia,  Italy,  Romania,  Slovakia,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with treatment-emergent adverse events (TEAEs) An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). From Entry Visit up to the Safety Visit (Month 26)
Primary Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). From Entry Visit until End of Down-Titration Period (Month 26)
Secondary Percentage of participants with serious adverse events (SAEs) during the study A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Results in permanent or significant disability/incapacity
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
From Entry Visit up to the Safety Visit (Month 26)
Secondary Percentage of participants with study drug-related treatment-emergent adverse events (TEAEs) An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). 'Drug related AEs' are the subset of AEs that the investigator considers as related to the study drug. From Entry Visit up to the Safety Visit (Month 26)
Secondary Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit A 1-hour electroencephalogram (EEG) will be performed. The awake hours from the EEG will be analyzed for absence seizures. Every 1-hour EEG will include hyperventilation as a standard provocation test at the beginning of the EEG. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received any permitted antiepileptic drugs including benzodiazepine in the 4 days prior to the EEG or during the EEG. From Full Evaluation Visit (Month 6) up to the Final Visit (Month 24)
Secondary Percentage of participants with absence seizure freedom based on diary over the entire evaluation period and by 3-month time intervals During the study, subjects will keep a diary to record daily seizure activity from Visit 1 until the final visit. Each seizure type experienced will be recorded. The participant will be considered as not meeting the criteria for absence seizure freedom if they use any permitted anti-epileptic drugs at anytime during the period, and/or complete less than 80% of diaries during the period. From Entry Visit up to the Final Visit (Month 24)
See also
  Status Clinical Trial Phase
Completed NCT00393666 - Why Are Patients With Absence Seizures Absent? A Brain Imaging Study N/A
Terminated NCT06153186 - Flunarizine for Treatment Resistant Absence Epilepsy Phase 2
Not yet recruiting NCT06315322 - A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy Phase 3
Recruiting NCT04666610 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy Phase 3
Completed NCT00088452 - Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study Phase 3
Terminated NCT03355300 - Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures Phase 2
Terminated NCT03336242 - Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures Phase 2
Completed NCT00361010 - A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy N/A
Completed NCT00041951 - Search for Genes Influencing Childhood Absence Epilepsy (CAE) Study N/A
Recruiting NCT06310772 - Assessing Comorbidities in Epilepsy Using Eye Movement Recordings