Clinical trial NCT06315322: A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Official title: A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Childhood Absence Epilepsy
Juvenile Absence Epilepsy
Keywords: Childhood Absence Epilepsy
Juvenile Absence Epilepsy
Phase 3
Brivaracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.


Eligibility criteria: Inclusion Criteria:

* Participants who previously participated in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
* Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator
* Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period.

A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.

- Capable of and provides informed consent/assent, and the participant's parent/legal representative/caregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)/Assent form and in this protocol

Exclusion Criteria:

* Participant has a history or presence of paroxysmal nonepileptic seizures
* 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
* Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
* 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 participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately 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 participant's ability to participate in this study
* Participant has known fructose intolerance or a known hypersensitivity to any components of BRV or excipients or a drug with similar chemical structure
* Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
* Participant is receiving any investigational drugs or using any experimental devices in addition to BRV
* Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or is experiencing an ongoing Serious adverse event (SAE)
* Participant has poor compliance with the visit schedule or IMP intake in the preceding study in the opinion of the Investigator

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) during the study
timeFrame: From Entry Visit up to the Safety Visit (up to 3 years)
measure: Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study
timeFrame: From Entry Visit up to the Safety Visit (up to 3 years)
Secondary outcomes:
measure: Incidence of serious adverse events (SAEs) during the study
timeFrame: From Entry Visit up to the Safety Visit (up to 3 years)
measure: Incidence of IMP related TEAEs during the study
timeFrame: From Entry Visit up to the Safety Visit (up to 3 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ep0224 50140
state: Alabama
city: Orange
country: United States
facility: Ep0224 50639
state: California
city: Miami
country: United States
facility: Ep0224 50268
state: Florida
city: New Brunswick
country: United States
facility: Ep0224 50638
state: New Jersey
city: Winston-Salem
country: United States
facility: Ep0224 50640
state: North Carolina
city: Tbilisi
country: Georgia
facility: Ep0224 20321
city: Tbilisi
country: Georgia
facility: Ep0224 20322
city: Tbilisi
country: Georgia
facility: Ep0224 20323
city: Tbilisi
country: Georgia
facility: Ep0224 20324
city: Messina
country: Italy
facility: Ep0224 40765
city: Milano
country: Italy
facility: Ep0224 40144
city: Pavia
country: Italy
facility: Ep0224 40764
city: Roma
country: Italy
facility: Ep0224 40629
city: Verona
country: Italy
facility: Ep0224 40763
city: Bucharest
country: Romania
facility: Ep0224 40767
city: Bucuresti
country: Romania
facility: Ep0224 40769
city: Iasi
country: Romania
facility: Ep0224 40768
city: Timisoara
country: Romania
facility: Ep0224 40770
city: Bardejov
country: Slovakia
facility: Ep0224 40771
city: Dubnica Nad Vahom
country: Slovakia
facility: Ep0224 40772
city: Terrassa
country: Spain
facility: Ep0224 40453
city: Uzhgorod
country: Ukraine
facility: Ep0224 20328
Study officials:
References: