An Extension Study to Evaluate the Safety and Tolerability of NBI-921352as Adjunctive Therapy in Subjects with Focal Onset Seizures (FOS)

Phase 1

• Conditions: Focal Onset Seizures (FOS); MedDRA version: 21.1Level: LLTClassification code 10016843Term: Focal seizuresSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-004265-12-IT
• Lead Sponsor: eurocrine Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-13
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Provided informed consent.
• Completed 11 weeks of treatment in Study NBI-921352-FOS2021.
• Anticipated use of stable treatment with at least 1 but not more than 4
ASMs during the Blinded Dose Conversion Period and for the first week
of the Open-Label Treatment Period.
• Female subjects of childbearing potential must agree to use
contraception consistently from Day 1 until the final study visit or 30
days after the last dose of study treatment, whichever is longer.
• Male subjects must agree to use effective barrier contraception
consistently from Day 1 until 30 days after the last dose of study
treatment.
• Be able to keep accurate seizure diaries
• Willing and able to comply with all study procedures and restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the
following criteria:
• Pregnant or breastfeeding or planning to become pregnant during the
study.
• Have developed any other disorder for which the treatment takes
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priority over the treatment of FOS or is likely to interfere with study
treatment or impair treatment compliance.
• Anticipated that the subject will require treatment with at least 1 of
the disallowed concomitant medications (Section 7.1.1) during the
study.
• Plan to use any investigational drug (other than the study treatment)
during the study.
• Any medical condition or personal circumstance that in the opinion of
the investigator exposes the subject to unacceptable risk by
participating in the study or prevents adherence to the protocol.
• In the investigator's opinion, the subject is not capable of adhering to
the protocol requirements, including the requirement to travel to the
study sites for study visits, or is unsuitable for any reason.

Study & Design

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