A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT03250377
• Date of registration: 31/07/2017
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SRL
• Public title: A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
• Scientific title: An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
• Date of first enrolment: August 5, 2017
• Target sample size: 217
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/ct2/show/NCT03250377
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

China, Japan

Contacts

• Name: UCB Cares
• Affiliation: 001 844 599 2273 (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male/female study participant from 16 years of age or older. Study participant who are
not legal adults may only be included where legally permitted and ethically accepted

- Study participant completed the Treatment Period and Transition Period of EP0083 or is
ongoing in N01379 sites in Japan

- Female study participants with childbearing potential are eligible if they use a
medically accepted contraceptive method

- Inclusion Criteria for directly enrollers only: Study participant has 1 to <8 partial
seizures (according to the 1981 International League Against Epilepsy (ILAE)
classification) during the 8 weeks prior to brivaracetam (BRV) administration

Exclusion Criteria:

- Study participant has developed hypersensitivity to any components of the
investigational medicinal product (IMP) or comparative drugs as stated in this
protocol during the course of the core study

- Severe medical, neurological or psychiatric disorders, or laboratory values which may
have an impact on the safety of the study participant

- Poor compliance with the visit schedule or medication intake in the previous BRV
studies

- Planned participation in any other clinical study of another investigational drug or
device during this study

- Pregnant or lactating woman

- Any medical condition which, in the Investigator's opinion, warrants exclusion

- Study participant has a lifetime history of suicide attempt or has suicidal ideation
in the past 6 months

- Study participant has >2 x upper limit of normal (ULN) of any of the following at the
Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST),
alkaline phosphatase (ALP), or >ULN total bilirubin (=1.5x ULN total bilirubin if
known Gilbert's syndrome)



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Partial Seizures With or Without Secondary Generalization

Epilepsy

Intervention(s)

Drug: Brivaracetam

Primary Outcome(s)

Percentage of study participants with treatment-emergent adverse events (TEAEs) [Time Frame: From study entry until Final Visit (up to 70 months)]

Secondary Outcome(s)

Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period [Time Frame: During the Evaluation Period (up to 70 months)]

Responder rate in partial seizure frequency per 28 days over the Evaluation Period for directly enrolled study participants [Time Frame: Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months)]

Percent change in partial seizure frequency per 28 days from Baseline of directly enrolled study participants to the Evaluation Period [Time Frame: Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months)]

Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period [Time Frame: During the Evaluation Period (up to 70 months)]

Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period for directly enrolled study particpants [Time Frame: During the Evaluation Period (up to 70 months)]

Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period for directly enrolled study particpants [Time Frame: During the Evaluation Period (up to 70 months)]

Responder rate in partial seizure frequency per 28 days over the Evaluation Period [Time Frame: Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)]

Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period [Time Frame: During the Evaluation Period (up to 70 months)]

Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period for directly enrolled study particpants [Time Frame: During the Evaluation Period (up to 70 months)]

Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period [Time Frame: Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)]

Secondary ID(s)

EP0085

Source(s) of Monetary Support

Please refer to primary and secondary sponsors