Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome

Phase 1

• Conditions: ennox-Gastaut Syndrome (LGS); MedDRA version: 20.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-002481-40-PL
• Lead Sponsor: Takeda Development Center Americas, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-17
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

1. Has documented clinical diagnosis of LGS.
2. Has had =8 MMD seizures each month in the 3 months prior to Screening based on the historical information and has had =8 MMD seizures per 28 days during the 4 to 6 week prospective Baseline Period.
3. Weighs =10 kg at the Screening Visit (Visit 1).
4. Failure to control seizures despite appropriate trials of at least 1 ASM based on historical information, and is currently on an antiseizure
therapy or other treatment options considered as standard of care (SOC).
5. Artisanal cannabidiols are allowed at a stable dose for at least 4 weeks before the screening visit (Visit 1); the dosing regimen and manufacturer should remain constant throughout the study. (Artisanal
cannabidiols will not be counted as ASMs.)
6. Currently taking 0 to 3 ASMs at stable doses for at least 4 weeks before the Screening Visit (Visit 1); Fenfluramine and cannabidiol
(Epidiolex) are allowed where available and counted as an ASM. ASM
dosing regimen must remain constant throughout the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 164
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Admitted to a medical facility and intubated for treatment of status
epilepticus 2 or more times in the 3 months immediately before
Screening (Visit 1). For the purpose of this exclusion criterion, status is
defined as continuous seizure activity lasting longer than 5 minutes or
repeated seizures without return to Baseline in between seizures.
2. Unstable, clinically significant neurologic (other than the disease
being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary,
hepatic, renal, metabolic, gastrointestinal, urologic, immunologic,
hematopoietic, endocrine disease, malignancy including progressive
tumors, or other abnormality that may impact the ability to participate in
the study or that may potentially confound the study results. It is the
responsibility of the investigator to assess the clinical significance;
however, consultation with the medical monitor may be warranted.
3. Considered by the investigator to be at imminent risk of suicide or
injury to self, others, or property, or the participant has attempted
suicide within 12 months before the Screening Visit (Visit 1).
Participants who have positive answers on item numbers 4 or 5 on the
Columbia suicide severity rating scale (C-SSRS) before dosing (Visit 2)
are excluded. This scale will only be administered to participants aged =
6 years.

Study & Design

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