An Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as 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-CZ

Lead Sponsor: eurocrine Biosciences, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

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 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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective for this study is to investigate the effect of NBI-921352 on long-term seizure control in subjects with FOS.<br>;Primary end point(s): Subject incidence of serious treatment-emergent adverse events (TEAEs), TEAEs leading to study treatment discontinuation, and fatal TEAEs;Timepoint(s) of evaluation of this end point: Throughout the study;Main Objective: The primary objective for this study is evaluate the long-term safety and tolerability of NBI-921352 administered for up to 107 weeks in subjects with FOS

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Percentage change from baseline in 28-day FOS frequency during the treatment period<br>• Treatment response defined as =50% reduction in 28-day FOS frequency during the treatment period compared with baseline;Timepoint(s) of evaluation of this end point: Baseline, Treatment Period

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