Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

NCT01364597 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: N012662011-000374-60
• Study Type: interventional
• Target: 257
• Locations: 12 countries
• Sites: 56

Brief Summary

This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.

Conditions

Epilepsy

Keywords

Brivaracetam; Epilepsy; Child; Infant; Adolescents; Partial onset seizures

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study

  TEAEs are defined as AEs that had onset on or after the day of first BRV dose.

  From Baseline to end of study (up to 10 years)

• Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study

  TEAEs are defined as AEs that had onset on or after the day of first BRV dose. A SAE was defined as an event that met 1 or more of the below criteria: a) Death, b) Life-threatening, (Life-threatening did not include a reaction that might have caused death had it occurred in a more severe form.) c) Significant or persistent disability/incapacity, d) Congenital anomaly/birth defect (including that occurring in a fetus), e) Important medical event that, based upon appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious, (Important medical events may have included allergic bronchospasm requiring intensive treatment in an emergency room \[ER\] or at home) f) Initial inpatient hospitalization or prolongation of hospitalization. (A participant admitted to a hospital, even if released on the same day, met the criteria for the initial inpatient hospitalization).

  From Baseline to end of study (up to 10 years)

Secondary Outcomes (9)

• Absolute Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on Daily Record Card [DRC])

  From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

• Percent Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on DRC Data)

  From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

• 50% Responder Rate for Participants ≥2 Years of Age for Total Seizures (All Types) (Based on DRC Data)

  From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

• Absolute Change in Average Daily Frequency (ADF) of Partial-onset-seizures (POS) in Participants <2 Years of Age With POS Only (Based on EEG Data)

  From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years)

• Percent Change in Average Daily Frequency (ADF) of Partial-onset-seizures (POS) in Participants <2 Years of Age With POS Only (Based on EEG Data)

  From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years)

Study Arms (1)

Brivaracetam

EXPERIMENTAL

Drug: Brivaracetam (BRV)

Interventions

Brivaracetam (BRV) DRUG

The max BRV dose will be 5.0 mg/kg/day, not to exceed a dose of 200 mg/day for subjects with body weight \>40kg. Subjects may receive oral solution or oral tablets. The LTFU subjects will start dosing in N01266 on the individualized BRV dose they were receiving at the completion of the core study. Subjects must be able to tolerate the min BRV dose specified in the core study to be eligible for entry into the Evaluation Period of N01266. Dose can be adjusted as considered necessary by the Investigator and required by the subject's medical condition. All subjects who prematurely discontinue the study should complete an EDV and have their BRV dose down titrated by a maximum of half the dose every week for a maximum of 4 weeks until a dose of 1 mg/kg/day (50 mg/day for subjects with body weights \>50kg) is reached.

Brivaracetam

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All Subjects:
• Informed Consent form (ICF) is signed and dated by the parent(s) or legal representative(s)
• Subject/legal representative is considered reliable and capable of adhering to the protocol
• For female subjects:
• Subject is not of childbearing potential
• OR if women of childbearing potential, and sexually active only if:
• Adequate Contraceptive method
• Negative pregnancy test
• Understands the consequences and potential risks of inadequately protected sexual activity, understands and properly uses contraceptive methods, and is willing to inform the Investigator of any contraception changes
• Long Term Follow-up Subjects:
• \- Male or female subjects having participated in a core study with a confirmed diagnosis of epilepsy and for whom a reasonable benefit from long-term administration of BRV is expected
• Directly Enrolled Subjects:
• Subject is a male or female ≥4 years to \<17 years of age
• Subject has a clinical diagnosis of partial-onset seizures (POS) according to the International League Against Epilepsy (ILAE) classification
• Subject has an EEG compatible with the clinical diagnosis of POS

You may not qualify if:

• All Subjects:
• Subject is a pregnant or nursing female
• Subject has severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the subject.
• Subject has planned participation in any clinical study of another investigational drug or device.
• Subject has chronic liver disease.
• Long Term Follow-up Subjects:
• Subject had hypersensitivity to BRV or excipients or comparative drugs as stated in this protocol during the course of the core study.
• Subject had poor compliance with the visit schedule or medication intake in the core study.
• Subject ≥6 years of age has a lifetime history of suicide attempt (including actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the EV. If a subject has active suicidal ideation without a specific plan as indicated by a positive response ("Yes") to Question 4 of Columbia-Suicide Severity Rating Scale (C SSRS) at the EV, the subject should be referred immediately to a Mental Healthcare Professional and may be excluded from the study based upon the Investigator's judgment of benefit/risk of continuing the subject in the study/on study medication.
• Directly Enrolled Subjects:
• Subject has previously received BRV.
• Subject had concomitant use of LEV at the ScrV. In addition, the use of LEV is prohibited for at least 4 weeks prior to the ScrV.
• Subject has epilepsy secondary to a progressive cerebral disease or tumor, or any other progressively neurodegenerative disease. Stable arteriovenous malformations, meningiomas or other benign tumors may be acceptable according to Investigator's opinion.
• Subject has a history of primary generalized epilepsy.
• Subject has a history of status epilepticus in the month immediately prior to the ScrV or during the Up Titration Period.

Sponsors & Collaborators

• UCB Pharma SA: lead

Study Sites (56)

N01266 243

Los Angeles, California, 90027, United States

Location

N01266 108

Gulf Breeze, Florida, 32561, United States

Location

N01266 103

Wellington, Florida, 33470, United States

Location

N01266 118

Chicago, Illinois, 60611, United States

Location

N01266 106

Boston, Massachusetts, 02111, United States

Location

N01266 101

Saint Paul, Minnesota, 55102, United States

Location

N01266 113

Chesterfield, Missouri, 63017, United States

Location

N01266 105

Buffalo, New York, 14222, United States

Location

N01266 252

New York, New York, 10029, United States

Location

N01266 104

Rochester, New York, 14642, United States

Location

N01266 237

Durham, North Carolina, 27710, United States

Location

N01266 107

Cincinnati, Ohio, 45229, United States

Location

N01266 111

Columbus, Ohio, 43205, United States

Location

N01266 114

Pittsburgh, Pennsylvania, 15201, United States

Location

N01266 117

Houston, Texas, 77030, United States

Location

N01266 202

Brussels, Belgium

Location

N01266 203

Brussels, Belgium

Location

N01266 201

Leuven, Belgium

Location

N01266 204

Leuven, Belgium

Location

N01266 502

Hradec Králové, Czechia

Location

N01266 504

Ostrava Prouba, Czechia

Location

N01266 240

Prague, Czechia

Location

N01266 207

Lille, France

Location

N01266 206

Paris, France

Location

N01266 218

Bayern, Germany

Location

N01266 209

Freiburg im Breisgau, Germany

Location

N01266 210

Budapest, Hungary

Location

N01266 224

Budapest, Hungary

Location

N01266 247

Budapest, Hungary

Location

N01266 222

Debrecen, Hungary

Location

N01266 232

Miskolc, Hungary

Location

N01266 211

Cork, Ireland

Location

N01266 212

Messina, Italy

Location

N01266 213

Parma, Italy

Location

N01266 238

Pavia, Italy

Location

N01266 239

Pavia, Italy

Location

N01266 230

Roma, Italy

Location

N01266 256

Roma, Italy

Location

N01266 223

Aguascalientes, Mexico

Location

N01266 611

Chihuahua City, Mexico

Location

N01266 609

Culiacán, Mexico

Location

N01266 603

Guadalajara, Mexico

Location

N01266 610

Monterrey, Mexico

Location

N01266 404

Bialystok, Poland

Location

N01266 403

Gdansk, Poland

Location

N01266 406

Kielce, Poland

Location

N01266 402

Krakow, Poland

Location

N01266 401

Poznan, Poland

Location

N01266 407

Szczecin, Poland

Location

N01266 405

Wroclaw, Poland

Location

N01266 309

Barcelona, Spain

Location

N01266 306

Madrid, Spain

Location

N01266 301

Palma de Mallorca, Spain

Location

N01266 248

Seville, Spain

Location

N01266 308

Valencia, Spain

Location

N01266 215

London, United Kingdom

Location

Related Publications (3)

• Lagae L, Klotz KA, Fogarasi A, Floricel F, Reichel C, Elshoff JP, Fleyshman S, Kang H. Long-term safety and efficacy of adjunctive brivaracetam in pediatric patients with epilepsy: An open-label, follow-up trial. Epilepsia. 2023 Nov;64(11):2934-2946. doi: 10.1111/epi.17754. Epub 2023 Sep 5.

  PMID: 37597326 RESULT

• Bourikas D, Elmoufti S, Elshoff JP, Little A, Pucylowski K, Moseley B, Lagae L. Long-term tolerability and efficacy of adjunctive brivaracetam in pediatric patients with generalized-onset seizures: Subgroup analysis of an open-label, follow-up trial. Epilepsy Behav. 2025 Oct;171:110569. doi: 10.1016/j.yebeh.2025.110569. Epub 2025 Jul 29.

  PMID: 40737960 RESULT

• Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.

  PMID: 26899665 DERIVED

Related Links

• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: August 1, 2011
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: October 20, 2025
• Results First Posted: August 29, 2022

Record last verified: 2025-09

Locations

FR (2); IE (1); ES (5); IT (6); BE (4); DE (2); ME (5); GB (1); CZ (3); US (15); PL (7); HU (5)