A Study of Soticlestat in Adults and Children With Rare Epilepsies
NCT ID: NCT03635073
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
156 participants
INTERVENTIONAL
2018-07-19
2025-07-30
Brief Summary
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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.
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Detailed Description
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Participants who rollover from previous blinded study will undergo up to 2 weeks of Dose Optimization Period (depending on the previous study) followed by Maintenance Period. Participants who rollover from an open-label study will continue on their current dose until development is stopped by the sponsor, or the product is approved for marketing, or at any time at the discretion of the sponsor. There will be a 4-week Safety Follow-up Period after the last dose in Maintenance Period, including a 2-week dose Tapering Period.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Soticlestat
Soticlestat tablets or mini-tablets.
Interventions
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Soticlestat
Soticlestat tablets or mini-tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
2. In the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat
Exclusion Criteria
2. Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving Soticlestat).
3. Participant is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration.
4. Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as 'yes' to suicidal ideation question 4 or 5 on the C-SSRS at Screening) or appearing suicidal per investigator judgment.
2 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Locations
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Xenosciences Inc
Phoenix, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Colorado Children's Hospital
Aurora, Colorado, United States
Colorado Children's Hospital
Aurora, Colorado, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, United States
University of South Florida
Tampa, Florida, United States
Pediatric Neurology PA
Winter Park, Florida, United States
Rare Disease Research, LLC
Atlanta, Georgia, United States
Rare Disease Research, LLC
Atlanta, Georgia, United States
Center for Rare Neurological Diseases
Norcross, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Bluegrass Epilepsy Research LLC
Lexington, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Minnesota Epilepsy Group PA
Saint Paul, Minnesota, United States
Max Benzaquen, M.D., PC
Chesterfield, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Children's Hospital at Saint Peter's University Hospital
New Brunswick, New Jersey, United States
NYU - Ambulatory Care Center (ACC)
New York, New York, United States
Columbia University Medical Center - PIN
New York, New York, United States
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, United States
Medical University of South Carolina Childrens Hospital - PIN
Charleston, South Carolina, United States
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth, Texas, United States
Monash Children's Hospital
Clayton, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Austin Hospital
Heidelberg West, Victoria, Australia
Hospital For Sick Children
Toronto, Ontario, Canada
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Peking University First Hospital
Beijing, , China
Beijing Children's Hospital,Capital Medical University
Beijing, , China
Beijing Children's Hospital,Capital Medical University
Beijing, , China
Xiangya Hospital Central South University
Changsha, , China
Xiangya Hospital of Central South University
Changsha, , China
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, Tel Aviv, Israel
Soroka University Medical Centre
Beersheba, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Schneider Children's Medical Center of Israel - Petah Tikvah - PIN
Petah Tikva, , Israel
Sheba Medical Center - PPDS
Ramat Gan, , Israel
Sheba Medical Center - PPDS
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, , Israel
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne Plejady
Krakow, , Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie
Warsaw, , Poland
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce, Świętokrzyskie Voivodeship, Poland
Centro Hospitalar Lisboa Central- Hospital Dona Estefania
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria
Lisbon, , Portugal
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, Madrid, Communidad Delaware, Spain
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Vithas La Salud
Granada, , Spain
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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U1111-1218-5515
Identifier Type: OTHER
Identifier Source: secondary_id
2018-002485-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502801-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-935-18-001
Identifier Type: -
Identifier Source: org_study_id
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