A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Childhood Absence Epilepsy Clinical Trial

Official title:

A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

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
• Start date: March 30, 2022
• Est. completion date: September 27, 2024

Study information

• Verified date: May 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Childhood Absence Epilepsy
• Epilepsy
• Epilepsy, Absence
• Juvenile Absence Epilepsy

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 116	Denver	Colorado
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)