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RECRUITINGPhase 3INTERVENTIONAL

A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form/assent, and the participant's parent/legal representative/caregiver provides signed willing to sign a consent form for minor participants, which includes compliance with the requirements and restrictions listed in the willing to sign a consent form form (ICF)/Assent form and in this protocol Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Brivaracetam Film-coated tablet

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.

DRUG

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 (20)

Ep0224 50140
Birmingham, Alabama, United States
Ep0224 50639
Orange, California, United States
Ep0224 50268
Miami, Florida, United States
Ep0224 50638
New Brunswick, New Jersey, United States
Ep0224 50640
Winston-Salem, North Carolina, United States
Ep0224 20321
Tbilisi, Georgia
Ep0224 20322
Tbilisi, Georgia
Ep0224 20323
Tbilisi, Georgia
Ep0224 20324
Tbilisi, Georgia
Ep0224 40144
Abbiategrasso, Italy
Ep0224 40765
Messina, Italy
Ep0224 40764
Pavia, Italy
Ep0224 40629
Roma, Italy
Ep0224 40766
Roma, Italy
Ep0224 40763
Verona, Italy
Ep0224 40767
Bucharest, Romania
Ep0224 40769
Bucharest, Romania
Ep0224 40768
Iași, Romania
Ep0224 40770
Timișoara, Romania
Ep0224 40771
Bardejov, Slovakia