Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut Syndromes

Phase 1

• Conditions: Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS); MedDRA version: 20.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem Organ Class: 100000004850; 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: EUCTR2021-002482-17-GR
• Lead Sponsor: Takeda Development Center Americas, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Been previously enrolled in a phase 3 soticlestat clinical study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 282
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 118
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from study enrollment if they meet any of the following criteria:
1.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.
2.Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) >450 ms confirmed with a repeat ECG using manual measurement of QTcF. Clinically significant ECG abnormalities should be discussed with the medical monitor.
3.Subject is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last dose of study drug.
4.Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Subjects who have positive answers on item numbers 4 or 5 on the C SSRS before dosing are excluded. This scale will only be administered to subjects aged =6 years.

Study & Design

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