A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)

Phase 1

• Conditions: Epileptic Encephalopathies: Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome; MedDRA version: 20.0Level: LLTClassification code 10073682Term: Dravet syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1Level: PTClassification code 10048816Term: Lennox-Gastaut syndromeSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 22.1Level: PTClassification code 10083005Term: CDKL5 deficiency disorderSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 23.0Level: LLTClassification code 10083952Term: Dup15q syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2022-001315-44-Outside-EU/EEA
• Lead Sponsor: Takeda Development Center America, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-24
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Clinical diagnosis of Dup 15q or CDKL5 deficiency disorder.
2. Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Two or more episodes of convulsive status epilepticus per 3 months requiring
hospitalization and intubation.
2. Currently receiving a study drug or participated in a clinical study involving another
investigational product in the previous month.

Study & Design

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