Summary

for people ages 2-35 (full criteria)
at UCLA
study started
estimated completion

Description

Summary

The purpose of this study is to investigate the effect of TAK-935 on the frequency of motor seizures for participants with 15q duplication syndrome or CDKL5 deficiency disorder during the Maintenance Period.

Official Title

A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 Deficiency Disorder (ARCADE Study)

Details

The drug being tested in this study is called TAK-935 (OV935). TAK-935 is being tested to treat people with 15q duplication syndrome or CDKL5 deficiency disorder. 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: 15q duplication syndrome or CDKL5 deficiency disorder.

All participants will be asked to take TAK-935 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 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.

Keywords

15q Duplication Syndrome CDKL5 Deficiency Disease Drug Therapy Brain Diseases Epilepsy Central Nervous System Diseases Autism Infantile spams Cholesterol 24S-hydroxylase inhibitor Anti-epilepsy drug Anticonvulsants Cyclin-dependent kinase-like 5 deficiency disorder RETT syndrome Chromosome 15q Syndrome Deficiency Diseases TAK-935 TAK-935 (OV935)

Eligibility

You can join if…

Open to people ages 2-35

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

You CAN'T join if...

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

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • Research Institute Children's Hospital Colorado accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT03694275
Phase
Phase 2
Study Type
Interventional
Last Updated