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)
At a glance
What is this study about?
Incidence of AEs., Change from Baseline in behavioral and adaptive functional measures using the Vineland Adaptive Behavior Scale (VABS)., Change from Baseline in behavior measures using total scores and subscale scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for subjects ≥6 years of age., Change from Baseline in the Columbia-Suicide Severity Rating Scale (CSSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment categories 1, 2, 3, 4, and 5 for subjects ≥6 years of age., Absolute values and change from Baseline in clinical laboratory assessments, vital sign measurements, body weight, and electrocardiogram (ECG) parameters., Incidence of potentially clinically significant clinical safety laboratory test values, vital signs, weight, height, and ECG evaluations.
Who may be eligible?
Age 18 Years to any · Sex: All
Locations (3)
- —Spain
- —Portugal
- —Poland
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
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