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)
Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Drug Therapy, Brain Diseases, Central Nervous System Diseases, Tuberous Sclerosis, CDKL5 deficiency disorder, Dup15Q syndrome, Anoxic brain injury, Infantile spams, West syndrome, Cortical dysplasia, SCN1A, OV-935, Cholesterol 24S-hydroxylase inhibitor, Seizure, Anti-epileptic drug, Anticonvulsants, Nervous System Diseases, Drop seizure, Atonic seizure
Eligibility Criteria
Inclusion Criteria:
- Male and female participants aged greater than or equal to (>=) 2 and less than or equal to (<=) 17 years
- Clinical diagnosis of DS or LGS
- Weight of >=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
Sites / Locations
- Phoenix Children's Hospital
- Children's Hospital Los Angeles
- Colorado Children's Hospital
- Nicklaus Children's Hospital
- Pediatric Neurology PA
- Rare Disease Research, LLC
- Center for Rare Neurological Diseases
- Ann and Robert H Lurie Childrens Hospital of Chicago
- Mayo Clinic - PPDS
- Northeast Regional Epilepsy Group
- Children's Hospital at Saint Peter's University Hospital
- Columbia University Medical Center
- Wake Forest Baptist Medical Center
- Medical University of South Carolina
- Cook Children's Medical Center
- Monash Children's Hospital
- Austin Hospital
- Hospital For Sick Children
- Peking University First Hospital
- Capital Medical University (CMU) - Beijing Children's Hospital
- Beijing Children's Hospital,Capital Medical University
- Xiangya Hospital Central South University
- Children's Hospital of Fudan University
- Shenzhen Children's Hospital
- Sheba Medical Center-PPDS
- Soroka University Medical Centre
- Bnai Zion Medical Center
- Edith Wolfson Medical Center
- Hadassah Medical Center
- Schneider Childrens Medical Center of Israel
- Tel Aviv Sourasky Medical Center
- Uniwersyteckie Centrum Kliniczne - PPDS
- NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
- Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
- Centrum Medyczne Plejady
- Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie
- Instytut Pomnik Centrum Zdrowia Dziecka
- Centro Hospitalar Lisboa Central- Hospital Dona Estefania
- Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
- Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte
- Clinica Universidad Navarra
- Hospital Vithas La Salud
- Hospital Ruber Internacional
- Hospital Universitari i Politecnic La Fe de Valencia
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
TAK-935
TAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20.
TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing <60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20.