Phase 2
N=141
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
Epilepsy · Dravet Syndrome · Lennox-Gastaut Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03650452 ↗Enrolled (actual)
141
Serious AEs
17.0%
Results posted
Feb 2021
Primary outcome: Primary: Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period — 3.11; -27.76 percent change — p=0.0007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAK-935 (Drug); Placebo (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period |
3.11; -27.76 | 0.0007 sig |
| SECONDARY Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period |
0.75; -30.05 | 0.0024 sig |
| SECONDARY Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period |
9.38; -36.50 | 0.0001 sig |
| SECONDARY Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period |
-1.90; -18.46 | 0.1470 |
| SECONDARY Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period |
29.7; 42.5; 16.2; 27.5; 2.7; 10.0 | — |
| SECONDARY Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period |
13.6; 66.7; 0; 41.7; 0; 20.8 | — |
| SECONDARY Change From Baseline in Clinician's Clinical Global Impression of Severity (CGI-S) Responses of Investigator Reported Impression of Efficacy and Tolerability of Study Drug |
-0.3; -0.2 | 0.6829 |
| SECONDARY Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935 |
12.2; 17.2; 2.0; 15.5; 85.7; 65.5 | — |
| SECONDARY Percentage of Participants With Caregiver Global Impression of Change (Care GI-C) Responses as Per the Parent/Family Reported Impression of Efficacy and Tolerability of TAK-935 |
2.0; 13.8; 12.2; 10.3; 18.4; 32.8 | — |
| SECONDARY Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy |
102.77; 102.20; -0.10 | — |
| SECONDARY Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy |
31.00; 32.12; 0.30; -6.29 | — |
Summary
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Male and female participants aged greater than or equal to (>=) 2 and less than or equal to ( =10 kilogram (kg) at the Screening visit
- Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose
- Failed to become and remain seizure free with trials of at least 2 AEDs
Exclusion Criteria
- Has been admitted to a medical facility and intubated for treatment of status epilepticus 2 or more times in the 3 months immediately prior to the screening visit
- Non-epileptic events that cannot be reliably distinguished from epileptic seizures
- Participation in a clinical study involving another study drug in the previous month
Data sourced from ClinicalTrials.gov (NCT03650452). 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.