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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 22 February 2021
Main ID:  NCT03650452
Date of registration: 27/08/2018
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: 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 ELEKTRA
Scientific title: 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 Patients With Developmental and/or Epileptic Encephalopathies
Date of first enrolment: August 8, 2018
Target sample size: 141
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03650452
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Australia Canada China Israel Poland Portugal Spain United States
Contacts
Name:     Medical Director Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male and female participants aged greater than or equal to (>=) 2 and less than or
equal to (<=) 17 years

2. Clinical diagnosis of DS or LGS

3. Weight of >=10 kilogram (kg) at the Screening visit

4. Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose

5. Failed to become and remain seizure free with trials of at least 2 AEDs

Exclusion Criteria:

1. 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

2. Non-epileptic events that cannot be reliably distinguished from epileptic seizures

3. Participation in a clinical study involving another study drug in the previous month



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All
Health Condition(s) or Problem(s) studied
Dravet Syndrome
Epilepsy
Lennox-Gastaut Syndrome
Intervention(s)
Drug: Placebo
Drug: TAK-935
Primary Outcome(s)
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period [Time Frame: Baseline; Maintenance Period: Weeks 9 to 20]
Secondary Outcome(s)
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 [Time Frame: Baseline and Week 20]
Change From Baseline in Plasma 24S-Hydroxycholesterol (24HC) Levels in Participants Treated With TAK-935 as an Adjunctive Therapy [Time Frame: Baseline and Week 24]
Change From Baseline in Seizure Frequency in Participants Treated With TAK-935 as an Adjunctive Therapy [Time Frame: Baseline and Week 20]
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period [Time Frame: Baseline; Maintenance Period: Weeks 9 to 20]
Percent Change From Baseline in Drop Seizure Frequency Per 28 Days in Participants With the Lennox-Gastaut Syndrome (LGS) Stratum During the Maintenance Period [Time Frame: Baseline; Maintenance Period: Weeks 9 to 20]
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period [Time Frame: Baseline; Treatment Period: Weeks 0 to 20]
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 [Time Frame: Week 20]
Percentage of Participants With Clinical Global Impression of Change (CGI-C) Responses as Per the Investigator Reported Impression of Efficacy and Tolerability TAK-935 [Time Frame: Week 20]
Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period [Time Frame: Maintenance Period: Weeks 9 to 20]
Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period [Time Frame: Maintenance Period: Weeks 9 to 20]
Secondary ID(s)
2018-002484-25
TAK-935-2002
U1111-1206-5522
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ovid Therapeutics Inc.
Ethics review
Results
Results available: Yes
Date Posted: 18/02/2021
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03650452
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