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
3 other identifiers
interventional
141
8 countries
44
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2018
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2018
CompletedFirst Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2020
CompletedResults Posted
Study results publicly available
February 18, 2021
CompletedFebruary 18, 2021
January 1, 2021
1.8 years
August 27, 2018
January 19, 2021
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period
Seizure frequency per 28 days is defined as total number of seizures (convulsive seizures for DS, drop seizures for LGS) reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline is defined as (frequency of seizures per 28 days during maintenance period - frequency of seizures per 28 days at baseline) divided by frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement.
Baseline; Maintenance Period: Weeks 9 to 20
Secondary Outcomes (10)
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Period
Baseline; Treatment Period: Weeks 0 to 20
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days in Participants With Dravet Syndrome Stratum During the Maintenance Period
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
Baseline; Maintenance Period: Weeks 9 to 20
Percentage of Participants With LGS Stratum Considered Treatment Responders Throughout the Maintenance Period
Maintenance Period: Weeks 9 to 20
Percentage of Participants With Dravet Syndrome Stratum Considered Treatment Responders Throughout the Maintenance Period
Maintenance Period: Weeks 9 to 20
- +5 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORTAK-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
EXPERIMENTALTAK-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Colorado Children's Hospital
Aurora, Colorado, 80045, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Pediatric Neurology PA
Orlando, Florida, 32819, United States
Rare Disease Research, LLC
Atlanta, Georgia, 30318, United States
Center for Rare Neurological Diseases
Norcross, Georgia, 30093, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611, United States
Mayo Clinic - PPDS
Rochester, Minnesota, 55905, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601, United States
Children's Hospital at Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Columbia University Medical Center
New York, New York, 10032, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Monash Children's Hospital
Clayton, Victoria, 3168, Australia
Austin Hospital
Heidelberg West, Victoria, 3081, Australia
Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
Peking University First Hospital
Beijing, 100034, China
Capital Medical University (CMU) - Beijing Children's Hospital
Beijing, 100045, China
Beijing Children's Hospital,Capital Medical University
Beijing, 100069, China
Xiangya Hospital Central South University
Changsha, 410078, China
Children's Hospital of Fudan University
Shanghai, 201102, China
Shenzhen Children's Hospital
Shenzhen, 518026, China
Sheba Medical Center-PPDS
Tel Litwinsky, Ramat Gan, 52621, Israel
Soroka University Medical Centre
Bear Sheva, 84101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Edith Wolfson Medical Center
Holon, 58100, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Schneider Childrens Medical Center of Israel
Petah Tikva, 49202, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, 60-355, Poland
Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk, Pomeranian Voivodeship, 80-211, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie
Warsaw, 02-091, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, 04-730, Poland
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce, Świętokrzyskie Voivodeship, 25-316, Poland
Centro Hospitalar Lisboa Central- Hospital Dona Estefania
Lisbon, 1169-045, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Largo da Maternidade de Julio DinisCentro Materno Infantil do Norte
Porto, 4050-651, Portugal
Clinica Universidad Navarra
Pamplona, Navarre, 31008, Spain
Hospital Vithas La Salud
Granada, 18008, Spain
Hospital Ruber Internacional
Madrid, 28034, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Related Publications (1)
Hahn CD, Jiang Y, Villanueva V, Zolnowska M, Arkilo D, Hsiao S, Asgharnejad M, Dlugos D. A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA). Epilepsia. 2022 Oct;63(10):2671-2683. doi: 10.1111/epi.17367. Epub 2022 Aug 4.
PMID: 35841234DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
August 28, 2018
Study Start
August 8, 2018
Primary Completion
June 9, 2020
Study Completion
July 20, 2020
Last Updated
February 18, 2021
Results First Posted
February 18, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.