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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Takeda Development Center Americas Inc.
Enrolment target
51
Start
23 Aug 2023

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

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