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A multicenter, open-label, pilot study of TAK-935 (OV935) in patients with 15Q duplication syndrome or CDKL5 deficiency disorder (ARCADE study)

NCT ID NCT03694275

NEW Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

20 people

The number who actually took part.

Started

Sep 2018

Finished

Jul 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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.

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Conditions

The condition(s) this trial relates to.

autism brain disorder CDKL5 disorder central nervous system disorder developmental and epileptic encephalopathy, 2 epilepsy hereditary mixed polyposis syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

15q duplication syndrome CDKL5 deficiency disease

Contacts and locations

Locations

  • Boston Children's Hospital Translational Neuroscience Center

    Boston, Massachusetts, 02115, United States

  • Center for Rare Neurological Diseases

    Norcross, Georgia, 30093, United States

  • Center for Rare Neurological Diseases (CRND)--Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Minnesota Epilepsy Group, P.A.

    Saint Paul, Minnesota, 55102, United States

  • New York University (NYU)

    New York, New York, 10017, United States

  • Research Institute Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • UCLA

    Los Angeles, California, 90095, United States