CTIS2022-502801-13-00Active, not recruitingPhase 1
A Phase 2, Prospective, Interventional, Open-Label, Multisite, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects with Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1) - TAK-935-18-001
Takeda Development Center Americas Inc.0 sites156 target enrollmentStarted: June 8, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 156
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 64 (—)
- Sex
- All
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.
Investigators
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