A study to test the safety and tolerability of brivaracetam in pediatric study participants withseizures.

Phase 1

• Conditions: Epilepsy; MedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-003664-29-IE
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-26
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion criteria for long-term follow-up (LTFU) study participants only:
- Study participants with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439] and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected;

Inclusion criteria for directly enrolled (DE) study participants only:
- Study participant is = 4 years to < 16 years of age;
- Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years;
- Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment (in the opinion of the Investigator) with at least 1 antiepileptic drug (AED);
- Study participant had at least 1 POS during the 4-week Screening Period;
- Study participant is taking at least 1 AED. Vagal nerve stimulator will be counted as a concomitant AED.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for all study participants:
- Study participant has, in the Investigator’s opinion, severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant;
- Study participant has any medical condition including chronic liver disease, which in the Investigator’s opinion, warrants exclusion;
- Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV). The use of antiepileptic drugs (AEDs) marketed for adults but not approved for pediatric use is not considered to be investigational” for the purposes of this study;
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study;

Exclusion criteria for long-term follow-up (LTFU) study participants only:
- Study participant had poor compliance with the visit schedule or medication intake in the BRV core study;
- Study participant = 6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months
as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS);

Exclusion criteria for directly enrolled (DE) study participants only:
- Study participant has a history of primary generalized epilepsy;
- Study participant has a history of status epilepticus in the 30 days immediately prior to the Screening Visit (ScrV) or during the Screening Period;
- Study participant has history or presence of known psychogenic nonepileptic seizures;
- Study participant has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary;
- Study participant 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 suppression, chronic hepatic disease, severe renal impairment, psychiatric disorder as per Investigator assessment);
- Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, according to the judgment of the Investigator;
- Study participant has a clinically significant ECG abnormality according to the Investigator;
- Study participant had major surgery within 6 months prior to the ScrV.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified