Open-label Follow-up Study of Soticlestat in Adults and Children with Developmental Epileptic Encephalopathies

Phase 1

• Conditions: Epileptic Encephalopathies: Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome, other adult DEEs.; MedDRA version: 20.0Level: LLTClassification code: 10073682Term: Dravet syndrome Class: 10010331; MedDRA version: 22.1Level: PTClassification code: 10083005Term: CDKL5 deficiency disorder Class: 100000004850; MedDRA version: 20.1Level: PTClassification code: 10048816Term: Lennox-Gastaut syndrome Class: 100000004852; MedDRA version: 23.0Level: LLTClassification code: 10083952Term: Dup15q syndrome Class: 10010331; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-502801-13-00
• Lead Sponsor: Takeda Development Center Americas Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

1. Subjects must have participated in a previous soticlestat study and meet one of the following conditions: -Successfully completed a Soticlestat clinical study. -Received at least 10 weeks of treatment (combined Dose Optimization and Maintenance Period) with the study drug in an antecedent placebo controlled blinded soticlestat clinical study and the subject did not have a serious or severe AE that, in the investigator's or sponsor's opinion, was related to the study drug and would make it unsafe for the subject to continue receiving the study drug. - In the opinion of the investigator, the subject has the potential to benefit from the administration of soticlestat (not applicable for Spain).

Exclusion Criteria

1. Clinically significant disease, that, in the investigator's opinion, precludes study participation. 2. Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as 'yes' to suicidal ideation question 4 or 5 on the C-SSRS at Screening) or appearing suicidal per investigator judgment.

Study & Design

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