NCT02687711: BASE

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

Completed Results posted Last updated 4 August 2021

What this trial tests

trial in Epilepsy With POS With or Without Secondary Generalization in 544 participants. Completed in 15 July 2020.

Timeline

1 February 2016

Primary endpoint
15 July 2020

15 July 2020

Quick facts

Lead sponsor	UCB Biopharma S.P.R.L.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	544
Start date	1 February 2016
Primary completion	15 July 2020
Estimated completion	15 July 2020
Sites	44 locations across Denmark, Italy, Netherlands, Ireland, United Kingdom, Germany, Hungary, Norway

Conditions studied

• Epilepsy With POS With or Without Secondary Generalization — all drugs for Epilepsy With POS With or Without Secondary Generalization →

Sponsor

UCB Biopharma S.P.R.L. — full company profile →

Who can join

16 and older, any sex, with Epilepsy With POS With or Without Secondary Generalization. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12 Primary · Month 12 (end of Observation Period)

Participants who remained in the study and were on BRV treatment for at least 1 year (\>=330 days) after their start of BRV were classed as having 12 months of treatment retention.

Group	Value	95% CI
Brivaracetam (FAS)	57.7	53.4 – 61.9

Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3 Secondary · Month 3

Participants who remained in the study and were on BRV treatment for at least 3 months (\>=90 days) after first BRV administration were classed as having 3 months of treatment retention.

Group	Value	95% CI
Brivaracetam (FAS)	82.4	79.0 – 85.6

Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6 Secondary · Month 6

Participants who remained in the study and were on BRV treatment for at least 6 months (\>=180 days) after first BRV administration were classed as having 6 months of treatment retention.

Group	Value	95% CI
Brivaracetam (FAS)	70.6	66.6 – 74.4

Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 Secondary · From Baseline (Day 1) to Month 3

Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency.

Group	Value	95% CI
Brivaracetam (FAS)	4.54	± 24.34

Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 Secondary · From Baseline (Day 1) to Month 6

Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency.

Group	Value	95% CI
Brivaracetam (FAS)	3.29	± 16.92

Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 Secondary · From Baseline (Day 1) to Month 12

Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency.

Group	Value	95% CI
Brivaracetam (FAS)	3.75	± 16.05

Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period Secondary · From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)

Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency.

Group	Value	95% CI
Brivaracetam (FAS)	1.69	± 26.59

Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 Secondary · From Baseline (Day 1) to Month 3

Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction.

Group	Value	95% CI
Brivaracetam (FAS)	-5.39	± 215.31

Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 Secondary · From Baseline (Day 1) to Month 6

Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction.

Group	Value	95% CI
Brivaracetam (FAS)	-10.64	± 369.03

Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 Secondary · From Baseline (Day 1) to Month 12

Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction.

Group	Value	95% CI
Brivaracetam (FAS)	7.05	± 351.75

Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period Secondary · From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)

Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction.

Group	Value	95% CI
Brivaracetam (FAS)	-9.54	± 308.89

Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 Secondary · Baseline (Day 1) to Month 3

Response was defined as a (greater than or equal to \[\>=\] 50%) reduction from Baseline in seizure frequency.

Group	Value	95% CI
Brivaracetam (FAS)	170

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline up to Month 12. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brivaracetam (SS)

Serious: 80/544 (15%)

Deaths: 2/544

Serious adverse events (74 terms)

Reaction	System	Brivaracetam (SS)
Seizure	Nervous system disorders	—
Suicidal ideation	Psychiatric disorders	—
Generalised tonic-clonic seizure	Nervous system disorders	—
Aggression	Psychiatric disorders	—
Partial seizures	Nervous system disorders	—
Epilepsy	Nervous system disorders	—
Seizure cluster	Nervous system disorders	—
Death	General disorders	—
Malaise	General disorders	—
Pneumonia	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Fall	Injury, poisoning and procedural complications	—
Focal dyscognitive seizures	Nervous system disorders	—
Petit mal epilepsy	Nervous system disorders	—
Status epilepticus	Nervous system disorders	—
Affective disorder	Psychiatric disorders	—
Agitation	Psychiatric disorders	—
Mood altered	Psychiatric disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Cleft lip	Congenital, familial and genetic disorders	—
Cleft palate	Congenital, familial and genetic disorders	—
Diplopia	Eye disorders	—
Abdominal pain lower	Gastrointestinal disorders	—
Dyspepsia	Gastrointestinal disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Brivaracetam (SS)
Drug ineffective	General disorders	—

Most-reported serious reactions: Seizure, Suicidal ideation, Generalised tonic-clonic seizure, Aggression, Partial seizures, Epilepsy, Seizure cluster, Death.

Data from ClinicalTrials.gov NCT02687711 adverse events section.

Sponsor's own description

Study is the first study after commercialization of brivaracetam. It is designed to collect real world information on the effectiveness of brivaracetam in patients with Partial Onset Seizure epislepsy who are treated in standard clinical practice.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness and tolerability of adjunctive brivaracetam in patients with focal seizures: Second interim analysis of 6-month data from a prospective observational study in Europe.
   Steinhoff BJ, Christensen J, Doherty CP, Majoie M, et al · · 2020 · cited 17× · PMID 32623096 · DOI 10.1016/j.eplepsyres.2020.106329
2. Effectiveness During 12-Month Adjunctive Brivaracetam Treatment in Patients with Focal-Onset Seizures in a Real-Life Setting: A Prospective, Observational Study in Europe.
   Steinhoff BJ, Christensen J, Doherty CP, Majoie M, et al · · 2025 · cited 4× · PMID 39976891 · DOI 10.1007/s40120-024-00697-4
3. Effectiveness and safety of early add-on therapy with brivaracetam in patients with poorly controlled focal seizures in routine clinical practice: BRIV-add study.
   Serrano-Castro PJ, Caballero-Martínez F, Campos-Lucas FJ, Campos-Fernández D, et al · · 2025 · cited 1× · PMID 40884534 · DOI 10.1002/epi4.70073
4. Health-Related Quality of Life and Cognitive Performance During 12-Month Adjunctive Brivaracetam Treatment in Patients with Focal-Onset Seizures: A Prospective, Observational Study in Europe.
   Rubio-Nazabal E, Majoie M, Schulz AL, Brock F, et al · · 2025 · cited 1× · PMID 39976892 · DOI 10.1007/s40120-024-00698-3