A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

• Register: ClinicalTrials.gov
• Last refreshed on: 20 November 2023
• Main ID: NCT03083665
• Date of registration: 28/02/2017
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SRL
• Public title: A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization
• Date of first enrolment: August 22, 2017
• Target sample size: 449
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03083665
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive

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

- Subjects having at least 8 partial seizures (according to the 1981 ILAE
classification) during the 8-Week Baseline Period with at least 2 partial seizures
during each 4-week interval of the Baseline Period

- Subjects having at least 2 partial seizures whether or not secondary generalization
per month during the 3 months preceding Visit 1

- Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug
[AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a
concomitant AED

Exclusion Criteria:

- Subject has history or presence of status epilepticus during the year preceding Visit
1 or during Baseline

- Subject is currently treated with levetiracetam

- Subject has taken levetiracetam within 90 days prior to Visit 1



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Partial Seizures With or Without Secondary Generalization

Epilepsy

Intervention(s)

Drug: Placebo

Drug: Brivaracetam

Primary Outcome(s)

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time Frame: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)]

Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period [Time Frame: From Baseline to 12-week Treatment Period]

Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal [Time Frame: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)]

Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) [Time Frame: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)]

Secondary Outcome(s)

50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period [Time Frame: From Baseline to 12-week Treatment Period]

Brivaracetam Plasma Concentration [Time Frame: Plasma samples were collected at >0-4hours, >4-8hours, >8hours in weeks 2, 4, 8, 12, and 14]

Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period [Time Frame: During the 12-week Treatment Period]

Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period [Time Frame: From Baseline to 12-week Treatment Period]

Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period [Time Frame: From Baseline to 12-week Treatment Period]

Time to 1st Partial Seizure During the 12-week Treatment Period [Time Frame: During the 12-week Treatment Period]

Time to 10th Partial Seizure During the 12-week Treatment Period [Time Frame: During the 12-week Treatment Period]

All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period [Time Frame: During the 12-week Treatment Period]

Time to 5th Partial Seizure During the 12-week Treatment Period [Time Frame: During the 12-week Treatment Period]

Secondary ID(s)

EP0083

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/11/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03083665