Phase 2
N=20
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)
15q Duplication Syndrome · CDKL5 Deficiency Disease
Bottom Line
View on ClinicalTrials.gov: NCT03694275 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Apr 2021
Primary outcome: Primary: Percent Change From Baseline in Motor Seizure Frequency Per 28 Days During the Maintenance Period — 11.7; -23.6 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Soticlestat (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Motor Seizure Frequency Per 28 Days During the Maintenance Period |
11.7; -23.6 | — |
| SECONDARY Percent Change From Baseline in Motor Seizure Frequency Per 28 Days During the Treatment Period |
13.4; -13.6 | — |
| SECONDARY Percentage of Participants Considered as Treatment Responders During the Maintenance Period |
62.5; 27.3; 12.5; 27.3; 12.5; 18.2 | — |
| SECONDARY Percent Change From Baseline in Frequency of Motor Seizures Longer Than 5 Minutes in Participants With CDD |
-54.0 | — |
| SECONDARY Proportion of Motor Seizure-free Days in Participants During the Maintenance Period |
0.1; 0.1 | — |
| SECONDARY Change From Baseline in Clinician's Global Impression of Severity (CGI-S) Responses of Investigator |
5.0; 5.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression |
33.3; 33.3; 0; 33.3; 50.0; 33.3 | — |
| SECONDARY Percentage of Participants With Care Clinical Global Impression of Change (CGI-C) Responses of Parent/Family |
0; 16.7; 16.7; 25.0; 33.3; 50.0 | — |
| SECONDARY Change From Baseline of Plasma 24S-hydroxycholesterol (24HC) Levels |
57.08; 115.29; -34.71; -75.64 | — |
| SECONDARY Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy |
128.4; 77.8; 13.2; -3.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03694275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.