Current Environment:

Summary

The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.

Conditions

15q Duplication Syndrome, CDKL5 Deficiency Disease

Recruitment Status

Completed

Detailed Description

The drug being tested in this study is called soticlestat. Soticlestat is being tested to treat people with Dup 15q or CDD. This study will assess the effects of TAK-935 on seizure frequency, safety. The study will enroll approximately 30 participants. Participants will be enrolled into 2 groups based on their diagnosis as: Dup 15q or CDD. All participants will be asked to take soticlestat tablets twice daily with or without food. The study comprises of 2 periods: Screening/Baseline Period and Treatment Period (Dose Optimization and Maintenance). The overall time to participate in this study is approximately 30 weeks, including 4 to 6 weeks Screening/Baseline Period, 20 weeks Treatment Period, 2 weeks Taper, and 2 weeks safety follow up period. Participants completing this study will have an option to enroll in the open-label extension (OLE) study, under a separate protocol.

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Dup 15q or CDKL5 deficiency disorder.
Currently taking 1 to 6 antiepileptic drugs (AEDs) at a stable dose.

Exclusion Criteria:

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

Intervention

Intervention Type

Intervention Name

Drug

Soticlestat

Phase

Phase 2

Gender

All

Minimum Age

2 Years

Maximum Age

55 Years

Download Date

April 20, 2021

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: