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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 February 2021
• Main ID: NCT03650452
• Date of registration: 27/08/2018
• Prospective Registration: No
• 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
• 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

Lennox-Gastaut Syndrome

Dravet Syndrome

Epilepsy

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)

Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period [Time Frame: Baseline; Treatment Period: Weeks 0 to 20]

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]

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]

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]

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 LGS Stratum Considered Treatment Responders Throughout the Maintenance Period [Time Frame: Maintenance Period: Weeks 9 to 20]

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]

Percentage of Participants With Dravet Syndrome 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.

Results

• Results available: Yes
• Date Posted: 18/02/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03650452