Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02687711
• Date of registration: 12/02/2016
• Prospective Registration: No
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures BASE
• Scientific title: A 12-Month Noninterventional, Postmarketing, Multicenter Study to Evaluate the Effectiveness of Briviact® (Brivaracetam) as Adjunctive Therapy in Patients With Epilepsy With Partial-onset Seizures in Daily Clinical Practice
• Date of first enrolment: February 1, 2016
• Target sample size: 544
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02687711
• Study type: Observational

Countries of recruitment

Denmark, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Spain, United Kingdom

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient has never been treated with brivaracetam (BRV) prior to enrollment in this
Non-Interventional Study (NIS)

- The decision by the treating physician to prescribe BRV is made independently of the
participation in the NIS

- Patient is a male or female =16 years of age

- Patient has a clinical diagnosis of epilepsy with partial-onset seizures POS with or
without secondary generalization

- Patient uses an epilepsy/seizure diary.

Exclusion Criteria:

No specific exclusion criteria



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

Health Condition(s) or Problem(s) studied

Epilepsy With POS With or Without Secondary Generalization

Primary Outcome(s)

Percentage of Patients remaining in the study and on BRV treatment at Month 12 [Time Frame: Month 12 (end of Observation Period)]

Secondary Outcome(s)

Absolute reduction in partial-onset seizure (POS) frequency [Time Frame: From Baseline (Day 1) to Month 12]

Percent of seizure free patients at 3 months [Time Frame: Month 3]

Percent reduction in partial-onset seizure (POS) frequency [Time Frame: From Baseline (Day 1) to end of Observation Period (up to Month 12)]

Number of responders based on percent reduction (=50%) in partial-onset seizure (POS) frequency at end of Observation Period [Time Frame: Baseline (Day 1) to end of Observation Period (up to Month 12)]

Number responders based on percent reduction (=50%) in partial-onset seizure (POS) frequency at 12 months [Time Frame: Baseline (Day 1) to Month 12]

Percent of responders based on percent reduction (=50%) in partial-onset seizure (POS) frequency at end of Observation Period [Time Frame: Baseline (Day 1) to end of Observation Period (up to Month 12)]

Absolute reduction in partial-onset seizure (POS) frequency [Time Frame: From Baseline (Day 1) to Month 3]

Number of seizure free patients at end of Observation Period [Time Frame: End of Observation Period (up to Month 12)]

Percentage of Patients remaining in the study and on BRV treatment at Month 6 [Time Frame: Month 6]

Number of seizure free patients at 6 months [Time Frame: Month 6]

Percent of seizure free patients at end of Observation Period [Time Frame: End of Observation Period (up to Month 12)]

Number of seizure free patients at 3 months [Time Frame: Month 3]

Percent reduction in partial-onset seizure (POS) frequency [Time Frame: From Baseline (Day 1) to Month 3]

Number of responders based on percent reduction ( =50%) in partial-onset seizure (POS) frequency at 3 months [Time Frame: Baseline (Day 1) to Month 3]

Number of responders based on percent reduction ( =50%) in partial-onset seizure (POS) frequency at 6 months [Time Frame: Baseline (Day 1) to Month 6]

Percent of responders based on percent reduction (=50%) in partial-onset seizure (POS) frequency at 12 months [Time Frame: Baseline (Day 1) to Month 12]

Percentage of Patients remaining in the study and on BRV treatment at Month 3 [Time Frame: Month 3]

Percent of seizure free patients at 12 months [Time Frame: Month 12]

Time to first seizure after first dose of brivaracetam [Time Frame: 12 months]

Absolute reduction in partial-onset seizure (POS) frequency [Time Frame: From Baseline (Day 1) to end of Observation Period (up to Month 12)]

Number of seizure free patients at 12 months [Time Frame: Month 12]

Percent of responders based on percent reduction ( =50%) in partial-onset seizure (POS) frequency at 6 months [Time Frame: Baseline (Day 1) to Month 6]

Absolute reduction in partial-onset seizure (POS) frequency [Time Frame: From Baseline (Day 1) to Month 6]

Percent of responders based on percent reduction ( =50%) in partial-onset seizure (POS) frequency at 3 months [Time Frame: Baseline (Day 1) to Month 3]

Percent of seizure free patients at 6 months [Time Frame: Month 6]

Percent reduction in partial-onset seizure (POS) frequency [Time Frame: From Baseline (Day 1) to Month 12]

Percent reduction in partial-onset seizure (POS) frequency [Time Frame: From Baseline (Day 1) to Month 6]

Secondary ID(s)

EP0077

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pharm Research Associates (UK) Ltd.