A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1)
Who is this study for? Patients with Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorde
What treatments are being studied? TAK-935
Status: Terminated
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study. Study treatments may continue as long as the participant is receiving benefit from it.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:
• Participants must have participated in a previous soticlestat study and meet one of the following conditions:
‣ Successfully completed a soticlestat clinical study.
⁃ Received at least 10 weeks of treatment with the study drug in an antecedent placebo-controlled blinded soticlestat clinical study and the participant did not have a serious or severe AE that, in the investigator's or sponsor's opinion, was related to the study drug and would make it unsafe for the participant to continue receiving the study drug.
• In the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat
Locations
United States
Arizona
Xenosciences Inc
Phoenix
California
David Geffen School of Medicine at UCLA
Los Angeles
David Geffen School of Medicine at UCLA
Los Angeles
Colorado
Colorado Children's Hospital
Aurora
Florida
Nicklaus Children's Hospital
Miami
Medsol Clinical Research Center Inc
Port Charlotte
Medsol Clinical Research Center Inc
Port Charlotte
University of South Florida
Tampa
Pediatric Neurology PA
Winter Park
Georgia
Rare Disease Research, LLC
Atlanta
Rare Disease Research, LLC
Atlanta
Center for Rare Neurological Diseases
Norcross
Illinois
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago
Kentucky
Bluegrass Epilepsy Research LLC
Lexington
Massachusetts
Boston Children's Hospital
Boston
Minnesota
Mayo Clinic - PIN
Rochester
Minnesota Epilepsy Group PA
Saint Paul
Missouri
Max Benzaquen, M.D., PC
Chesterfield
North Carolina
Wake Forest Baptist Medical Center - PPDS
Winston-salem
New Jersey
Northeast Regional Epilepsy Group
Hackensack
Children's Hospital at Saint Peter's University Hospital
New Brunswick
New York
Columbia University Medical Center - PIN
New York
NYU - Ambulatory Care Center (ACC)
New York
South Carolina
Medical University of South Carolina Childrens Hospital - PIN
Charleston
Texas
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth
Other Locations
Australia
Monash Children's Hospital
Clayton
Austin Hospital
Heidelberg
Austin Hospital
Heidelberg West
Canada
Hospital For Sick Children
Toronto
China
Beijing Children's Hospital,Capital Medical University
Beijing
Beijing Children's Hospital,Capital Medical University
Beijing
Peking University First Hospital
Beijing
Xiangya Hospital Central South University
Changsha
Xiangya Hospital of Central South University
Changsha
Children's Hospital of Fudan University
Shanghai
Shenzhen Children's Hospital
Shenzhen
Israel
Soroka University Medical Centre
Beersheba
Bnai Zion Medical Center
Haifa
Edith Wolfson Medical Center
Holon
Schneider Children's Medical Center of Israel - Petah Tikvah - PIN
Petah Tikva
Sheba Medical Center - PPDS
Ramat Gan
Sheba Medical Center - PPDS
Ramat Gan
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce
Centrum Medyczne Plejady
Krakow
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie
Warsaw
Portugal
Centro Hospitalar Lisboa Central- Hospital Dona Estefania
Lisbon
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon
Spain
Hospital Vithas La Salud
Granada
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid
Clinica Universidad Navarra
Pamplona
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Time Frame
Start Date: 2018-07-19
Completion Date: 2025-07-30
Participants
Target number of participants: 156
Treatments
Experimental: Soticlestat
Treatment: Soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasts until development is stopped by the sponsor, or the product is approved for marketing, or at any time at the discretion of the sponsor.
Related Therapeutic Areas
Sponsors
Leads: Takeda