A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Du… (NCT03694275) | Clinical Trial Compass
CompletedPhase 2
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)
United States20 participantsStarted 2018-09-10
Plain-language 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.
Who can participate
Age range
2 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 pilot study of soticlestat specifically for Dup15q or CDKL5 deficiency disorder, what do the results so far tell us about whether it actually reduced motor seizure frequency, and how confident can we be in those findings given the smaller scale of a pilot study?
2Given that this trial has already completed, has my doctor seen or reviewed any published data from the ARCADE study, and does that evidence change how they think about soticlestat as an option for my child's condition?
3This trial focused on measuring changes in motor seizure frequency — but my child may have other types of seizures too, so is there any information from this study about how soticlestat affected non-motor seizures or overall quality of life?
4Since this was an open-label study where everyone knew they were receiving the drug, how does that affect how we should interpret the results, and does my doctor think a larger or blinded trial would be needed before this becomes a standard treatment option?
5Before considering soticlestat based on this trial, are there currently approved or better-established treatments for Dup15q or CDKL5 deficiency disorder that my doctor would recommend trying first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Motor Seizure Frequency Per 28 Days During the Maintenance Period