New epilepsy drug shows promise for kids in Long-Term safety trial

NCT ID NCT01364597

Disease control Sponsor: UCB Pharma SA Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of brivaracetam, a seizure medication, when added to existing treatment in 257 children with epilepsy. The main goal was to track side effects over time. Researchers also measured how well the drug controlled seizures. The results help doctors understand if brivaracetam is a safe option for managing epilepsy in kids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: brivaracetam
What this could lead to: If successful, this could confirm brivaracetam as a safe and effective add-on option to help control seizures in children with epilepsy.
What could go wrong: This is a single-arm, open-label study without a placebo group, so results may be less definitive. Side effects are possible, and the drug is meant to manage, not cure, epilepsy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

257 people

The number who actually took part.

Started

Aug 2011

Finished

Feb 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

28 days to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 * Subject has been observed to have uncontrolled POS after an adequate course of treatment (in the opinion of the Investigator) with at least 1 antiepileptic drug (AED; concurrently or sequentially) * Subject had at least 1 seizure (POS) during the 3 weeks before the Screening Visit (ScrV) * Subject is taking at least 1 AED. All AEDs need to be at a stable dose for at least 7 days before the ScrV. Vagal nerve stimulator stable for at least 2 weeks before the ScrV is allowed and will be counted as a concomitant AED. Benzodiazepines taken more than once a week (for any indication) will be considered as a concomitant AED Exclusion Criteria: 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 \>1.5x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>1.0xULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are \>ULN and \<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin \<35%). N01349 subjects with a total bilirubin \> ULN may be considered for the study if benign unconjugated hyperbilirubinemia is suspected in the context of prolonged neonatal jaundice, after discussion with the medical monitor. For randomized subjects with a baseline result \>ULN for ALT, AST, ALP, or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the eCRF. If subject has \>ULN ALT, AST, or ALP that does not meet the exclusion limit at the baseline referenced in Table 5-1 for LTFU subjects and at the Screening Visit for directly enrolled subjects, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. This includes re-screening. * 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. * Subject has a history or presence of pseudoseizures. * Subject is suffering only from febrile seizures. * Subject is on felbamate with less than 18 months continuous exposure. Subject who has taken felbamate for a combined duration of treatment and wash out of \<18 months before the ScrV. * Subjects treated with vigabatrin who have visual field defects. * Subject has an allergy to pyrrolidone derivatives or investigational product excipients or a history of multiple drug allergies. * Subject has any clinically significant acute or chronic illness as determined during the physical examination or from other information available to the Investigator (eg, bone marrow depression, chronic hepatic disease, severe renal impairment, psychiatric disorder). * Subject has an underlying disease or is receiving a treatment that may interfere with the absorption, distribution, metabolism, and elimination of the study drug. * Subject has any medical condition that might interfere with his/her study participation (eg, serious infection or scheduled elective surgery). * Subject has a terminal illness. * Subject has any clinically significant deviations from reference range values for laboratory parameters as determined by the Investigator. * Subject has a clinically relevant ECG abnormality according to the Investigator. * Subject had major surgery within 6 months prior to the ScrV. * Subject received any investigational drug or device within the 30 days prior to the ScrV.

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Conditions

The condition(s) this trial relates to.

epilepsy focal epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy

Contacts and locations

Locations

N01266 101

Saint Paul, Minnesota, 55102, United States
N01266 103

Wellington, Florida, 33470, United States
N01266 104

Rochester, New York, 14642, United States
N01266 105

Buffalo, New York, 14222, United States
N01266 106

Boston, Massachusetts, 02111, United States
N01266 107

Cincinnati, Ohio, 45229, United States
N01266 108

Gulf Breeze, Florida, 32561, United States
N01266 111

Columbus, Ohio, 43205, United States
N01266 113

Chesterfield, Missouri, 63017, United States
N01266 114

Pittsburgh, Pennsylvania, 15201, United States
N01266 117

Houston, Texas, 77030, United States
N01266 118

Chicago, Illinois, 60611, United States
N01266 201

Leuven, Belgium
N01266 202

Brussels, Belgium
N01266 203

Brussels, Belgium
N01266 204

Leuven, Belgium
N01266 206

Paris, France
N01266 207

Lille, France
N01266 209

Freiburg im Breisgau, Germany
N01266 210

Budapest, Hungary
N01266 211

Cork, Ireland
N01266 212

Messina, Italy
N01266 213

Parma, Italy
N01266 215

London, United Kingdom
N01266 218

Bayern, Germany
N01266 222

Debrecen, Hungary
N01266 223

Aguascalientes, Mexico
N01266 224

Budapest, Hungary
N01266 230

Roma, Italy
N01266 232

Miskolc, Hungary
N01266 237

Durham, North Carolina, 27710, United States
N01266 238

Pavia, Italy
N01266 239

Pavia, Italy
N01266 240

Prague, Czechia
N01266 243

Los Angeles, California, 90027, United States
N01266 247

Budapest, Hungary
N01266 248

Seville, Spain
N01266 252

New York, New York, 10029, United States
N01266 256

Roma, Italy
N01266 301

Palma de Mallorca, Spain
N01266 306

Madrid, Spain
N01266 308

Valencia, Spain
N01266 309

Barcelona, Spain
N01266 401

Poznan, Poland
N01266 402

Krakow, Poland
N01266 403

Gdansk, Poland
N01266 404

Bialystok, Poland
N01266 405

Wroclaw, Poland
N01266 406

Kielce, Poland
N01266 407

Szczecin, Poland
N01266 502

Hradec Králové, Czechia
N01266 504

Ostrava Prouba, Czechia
N01266 603

Guadalajara, Mexico
N01266 609

Culiacán, Mexico
N01266 610

Monterrey, Mexico
N01266 611

Chihuahua City, Mexico

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