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-BE
• 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: 2021-12-20
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Subject must have:
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

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.
3. Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Particpants who have positive answers on item numbers 4 or 5 on the CSSRS 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