A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF BRIVARACETAM IN NEONATES WITH<br>REPEATED ELECTROENCEPHALOGRAPHIC SEIZURES

Phase 2

Withdrawn

• Conditions: 10014623; repeated electroencephalographic seizures; seizures

• Registration Number: NL-OMON50223
• Lead Sponsor: CB Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

1. An Independent Ethics Committee (IEC)-approved written ICF is signed and
dated by the parent(s) or legal representative(s).
2a. Confirmation on VEEG of *2 minutes of cumulative ENS or *3 identifiable ENS
prior to entering the Evaluation Period (ENS is defined as a seizure lasting
for at least 10 seconds on VEEG), despite receiving previous AED treatment for
the treatment of electroencephalographic seizures.
The occurrence of ENS during an up to 1-hour period must be confirmed either by
the local or central VEEG reader prior to drug administration. Preferably, the
central VEEG reader should confirm the required ENS.
3. Subject is male or female and must be at least 34 weeks of CGA. In addition,
term neonates up to 27 days of PNA and preterm neonates up to 40 weeks of PMA
and 27 days of PNA can be enrolled.
4. Subject weighs at least 2.3kg at the time of enrollment.
5. Subjects with or without concomitant hypothermia treatment.

Exclusion Criteria

1a. Subject receiving AED treatment other than PB, MDZ, PHT, LEV (*60mg/
kg/day), or LDC for the treatment of seizures prior to or at the time of
enrollment (Confirmatory Cohorts only).
2. Subject with seizures responding to previous AED treatment immediately prior
to BRV treatment, pyridoxine treatment, or correction of metabolic disturbances
(hypoglycemia, hypomagnesemia, or hypocalcemia).
3. Subject requires extra corporeal membrane oxygenation.
4. Subject has seizures related to prenatal maternal drug use or drug
withdrawal.
5. Subject has known severe disturbance of hemostasis, as assessed by the
Investigator.
6. Subject has a poor prognosis for survival, as judged by the Investigator.
7a. Subject has 2x upper limit of normal (ULN) of any of the following:
aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
phosphatase (ALP), with the following exception:
For subjects with perinatal asphyxia, elevation of AST, ALT or ALP <5x
ULN is acceptable, if initial and peak elevation of liver function tests (LFTs)
occurs within 5 days after birth, and the time course of LFT elevation is
compatible with hepatic injury due to perinatal asphyxia.
The determination of ULN will be based on the subject's gestational age
(GA) and the site*s normal range values for the respective GA.
8a. Subject has direct (conjugated) bilirubin levels >2mg/dL.
9. Subject requiring or expected to require phototherapy or exchange
transfusion due to elevated bilirubin.
10. Subject with rapidly increasing bilirubin that may preclude the subject
from inclusion in the study at the discretion of the Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified