Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06315322
Other study ID # EP0224
Secondary ID 2023-508095-11-0
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 14, 2024
Est. completion date February 28, 2029

Study information

Verified date May 2024
Source UCB Pharma
Contact UCB Cares
Phone 1-844-599-2273 (USA)
Email ucbcares@ucb.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date February 28, 2029
Est. primary completion date February 28, 2029
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design


Intervention

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.
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
n/a

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma SRL

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) during the study 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 (up to 3 years)
Primary Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study 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 (up to 3 years)
Secondary Incidence of 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 (up to 3 years)
Secondary Incidence of IMP related TEAEs during the study 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 (up to 3 years)
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
Enrolling by invitation NCT05109234 - 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 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