A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome

February 25, 2024 updated by: Takeda

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)

The aims of the study are:

  • to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome.
  • to assess the safety profile of soticlestat when given in combination with other therapies.

Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The drug being tested in this study is called soticlestat (TAK-935). Soticlestat will be assessed for efficacy, safety, and tolerability in pediatric and adult participants with LGS.

The study will enroll approximately 234 patients. Participants will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to receive standard of care (SOC) plus one of the following adjunctive therapies which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  1. Soticlestat
  2. Placebo (dummy inactive pill - this is a tablet/mini-tablet that looks like the study drug but has no active ingredient)

Participants will receive soticlestat or matching placebo based on their weight in the 4-week Titration Period. Following the Titration Period, participants will continue to receive the same dose in the 12-week Maintenance Period. The dose will then be down-tapered if participants decide to discontinue the treatment and/or are not deemed eligible to continue in Open-label extension (OLE).

This multi-center trial will be conducted worldwide. The overall time to participate in the study will be from 22-25 weeks. At the end of the treatment period, participants have the option to either complete the study and taper off the investigational product or to enter the OLE if they meet eligibility requirements. If participants discontinue, they will be followed-up on phone call approximately 14 days after the last dose of study drug for safety.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Sydney Children's Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Queensland Childrens Hospital
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Brussels, Belgium
        • Hôpital Universitaire des Enfants Reine Fabiola
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen PIN
    • Brabant Wallon
      • Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium, 1340
        • Centre Neurologique William Lennox
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Childrens Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4H4
        • Child and Family Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100045
        • Beijing Children's Hospital,Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Children's Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • The Second Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510623
        • Guangzhou Women and Children's Medical Center
      • Shenzhen, Guangdong, China, 518026
        • Shenzhen Children's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430010
        • Wuhan Childrens hospital
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial Children's Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University
      • Shanghai, Shanghai, China, 200040
        • Children's Hospital of Shanghai
      • Marseille, France, 13386
        • Hopitaux de La Timone
      • Paris, France, 75019
        • Hopital Robert Debre
      • Paris, France, 75015
        • Hôpital Necker - Enfants Malades
    • Cote-d'Or
      • Dijon, Cote-d'Or, France, 21079
        • CHRU Dijon Hopital General
    • Nord
      • Lille, Nord, France, 59000
        • Hôpital Roger Salengro
    • Bayern
      • Vogtareuth, Bayern, Germany, 83569
        • Schon Klinik Vogtareuth
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60528
        • Klinikum der Johann-Wolfgang Goethe-Universitat
    • Nordrhein-Westfalen
      • Bielefeld, Nordrhein-Westfalen, Germany, 33617
        • Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
    • Sachse
      • Radeberg, Sachse, Germany, 1454
        • Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
      • Larisa, Greece, 411 10
        • University General Hospital of Larissa
      • Thessaloniki, Greece, 546 42
        • Hippokration Hospital
    • Attiki
      • Chaidari, Attiki, Greece, 124 62
        • Attikon University General Hospital
      • Budapest, Hungary, 1145
        • Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
      • Budapest, Hungary, 1023
        • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
      • Budapest, Hungary, 1143
        • Bethesda Gyermekkórház
    • Baranya
      • Pecs, Baranya, Hungary, 7623
        • Pecsi Tudomanyegyetem
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40139
        • Ospedale Bellaria
    • Lazio
      • Roma, Lazio, Italy, 168
        • Fondazione Policlinico Universitario A Gemelli
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
    • Aiti
      • Nagakute-Shi, Aiti, Japan, 480-1195
        • Aichi Medical University Hospital
    • Hukuoka
      • Fukuoka-Shi, Hukuoka, Japan, 813-0017
        • Fukuoka Children's Hospital
    • Kumamoto
      • Kumamoto-Shi, Kumamoto, Japan, 862-0947
        • Kumamoto-Ezuko Medical Center for The Severely Disabled
    • Nagasaki
      • Omura-Shi, Nagasaki, Japan, 856-0835
        • National Hospital Organization Nagasaki Medical Center
    • Niigata
      • Niigata-Shi, Niigata, Japan, 950-2074
        • National Hospital Organization Nishi-Niigata Chuo National Hospital
    • Okayama
      • Okayama-city, Okayama, Japan, 700-8558
        • Okayama University Hospital
    • Osaka
      • Neyagawa-Shi, Osaka, Japan, 572-0085
        • Yasuhara Childrens Clinic
      • Osaka-Shi, Osaka, Japan, 534-0021
        • Osaka City General Hospital
      • Suita-Shi, Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Sizuoka
      • Shizuoka-Shi, Sizuoka, Japan, 420-0953
        • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
    • Tokyo
      • Kodaira-Shi, Tokyo, Japan, 187-0031
        • National Center of Neurology and Psychiatry
      • Riga, Latvia, LV-1004
        • Childrens University Hospital
    • Noord-Brabant
      • Heeze, Noord-Brabant, Netherlands, 5591 VE
        • Kempenhaeghe - PPDS
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 BV
        • Stichting Epilepsie Instellingen Nederland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Poznan, Poland, 60-355
        • Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-363
        • Centrum Medyczne Plejady
      • Ekaterinburg, Russian Federation, 620144
        • UGMK-Zdorojie, LLC
      • Belgrade, Serbia, 11000
        • Clinic for Neurology and Psychiatry for Children and Youth
      • Belgrade, Serbia, 11000
        • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
      • Nis, Serbia, 18 000
        • University Clinical Center Nis
      • Novi Sad, Serbia, 21 000
        • Children and Youth Health Care Institute of Vojvodina
      • Barcelona, Spain, 8035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de Malaga Hospital General
      • Sevilla, Spain, 41013
        • Centro de Neurologia Avanzada
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad Navarra
      • Ivano-Frankivsk, Ukraine, 76018
        • Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
      • Kyiv, Ukraine, 4080
        • CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
      • Kyiv, Ukraine, 4209
        • SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
    • Dnipropetrovs'ka Oblast
      • Dnipro, Dnipropetrovs'ka Oblast, Ukraine, 49100
        • Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
      • Dnipro, Dnipropetrovs'ka Oblast, Ukraine, 49101
        • Communal Non-profit Enterprise City Childrens Clinical Hospital #6 of DCC
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Childrens Hospital
      • Tucson, Arizona, United States, 85718
        • Center for Neurosciences
    • California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA
      • San Francisco, California, United States, 94143
        • University of California Benioff Children's Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Children's Hospital Colorado.
    • Florida
      • Winter Park, Florida, United States, 32789
        • Pediatric Neurology PA
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Clinical Integrative Research Center of Atlanta
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics - (CRS)
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Midatlantic Epilepsy and Sleep Center
    • Minnesota
      • Roseville, Minnesota, United States, 55113
        • Minnesota Epilepsy Group PA
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
    • New York
      • New York, New York, United States, 10016
        • NYU Comprehensive Epilepsy Center
      • New York, New York, United States, 10001
        • Premier Healthcare Inc.
      • New York, New York, United States, 10075
        • Northwell Health Physician Partners - Neurology at Lenox Hill
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hospital for Children
      • York, Pennsylvania, United States, 17403
        • WellSpan Oncology Research
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Children Hospital - PIN
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center - Jane and John Justin Neurosciences Center
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • University of Utah - Primary Children's Hospital - PPDS
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
      • Tacoma, Washington, United States, 98402
        • MultiCare Institute for Research & Innovation (Tacoma)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Has documented clinical diagnosis of LGS.
  2. Has had ≥8 MMD seizures each month in the 3 months prior to Screening based on the historical information and has had ≥8 MMD seizures per 28 days during the 4 to 6 week prospective Baseline Period.
  3. Weighs ≥10 kg at the Screening Visit (Visit 1).
  4. Failure to control seizures despite appropriate trials of at least 1 ASM based on historical information, and is currently on an antiseizure therapy or other treatment options considered as standard of care (SOC).
  5. Artisanal cannabidiols are allowed at a stable dose for at least 4 weeks before the screening visit (Visit 1); the dosing regimen and manufacturer should remain constant throughout the study. (Artisanal cannabidiols will not be counted as ASMs.)
  6. Currently taking 0 to 3 ASMs at stable doses for at least 4 weeks before the Screening Visit (Visit 1); Fenfluramine and cannabidiol (Epidiolex) are allowed where available and counted as an ASM. ASM dosing regimen must remain constant throughout the study.

Exclusion Criteria:

  1. Admitted to a medical facility and intubated for treatment of status epilepticus 2 or more times in the 3 months immediately before Screening (Visit 1). For the purpose of this exclusion criterion, status is defined as continuous seizure activity lasting longer than 5 minutes or repeated seizures without return to Baseline in between seizures.
  2. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
  3. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within 12 months before the Screening Visit (Visit 1). Participants who have positive answers on item numbers 4 or 5 on the Columbia suicide severity rating scale (C-SSRS) before dosing (Visit 2) are excluded. This scale will only be administered to participants aged ≥6 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soticlestat

Participants weighing <45 kg: Soticlestat, mini-tablets, at the dose of 40 mg to 200 mg, orally or via gastrostomy tube (G-tube) or low-profile gastric tube (MIC-KEY button) or jejunostomy tube (J-tube), twice daily (BID) based on body weight up to 4 weeks in Titration Period. Participants will continue to receive the dose that they are on at the end of the titration period, for 12 weeks in the Maintenance Period. Total duration of the treatment will be up to 16 weeks (Treatment Period). Dose will be tapered down if participants decide to discontinue the treatment.

Participants weighing ≥45 kg: Soticlestat mini-tablets or tablets with a starting dose of 100 mg BID followed by 200 mg BID and, then 300 mg BID, up to 4 weeks in Titration Period. Participants will continue to receive 300 mg BID for 12 weeks in the Maintenance Period. Total duration of the treatment will be up to 16 weeks (Treatment Period). Dose will be tapered down if participants decide to discontinue the treatment.

Soticlestat mini-tablets or tablets.
Other Names:
  • TAK-935
Placebo Comparator: Placebo
Soticlestat placebo-matching mini-tablets or tablets, orally or via G-tube or MIC-KEY button or J-tube, BID, up to 4 weeks in the Titration Period. Participants will continue to receive the soticlestat placebo-matching mini-tablets or tablets for 12 weeks in the Maintenance Period. The total duration of the treatment will be up to 16 weeks (Treatment Period). Soticlestat matching tapering will be done to maintain the blind if participants decide to discontinue the treatment.
Soticlestat placebo-matching mini-tablets or tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Full Treatment Period
Time Frame: Baseline up to Week 16
MMD seizure frequency per 28 days is defined as total number of MMD seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline will be defined as (frequency of seizures per 28 days during full Treatment Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100.
Baseline up to Week 16
Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Maintenance Period (EMA Region Specific)
Time Frame: Baseline up to Week 16
MMD seizure frequency per 28 days is defined as total number of MMD seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline will be defined as (frequency of seizures per 28 days during the Maintenance Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100. This outcome measure is European Medicines Agency (EMA) region specific.
Baseline up to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responders During the Maintenance Period
Time Frame: Baseline up to Week 16
Responders are defined as those with ≥50% reduction from Baseline in MMD seizures during the Maintenance Period.
Baseline up to Week 16
Percentage of Responders During the Full Treatment Period
Time Frame: Baseline up to Week 16
Responders are defined as those with ≥50% reduction from Baseline in MMD seizures during the full Treatment Period.
Baseline up to Week 16
Percentage of Participants with ≤0%, >0% to ≤25%, >25% to ≤50%, >50% to ≤75%, >75% to ≤100% Reduction in MMD Seizure in a Cumulative Response Curve
Time Frame: Baseline up to Week 16
Baseline up to Week 16
Caregiver Global Impression of Improvement (Care GI-I) Score
Time Frame: Baseline up to Week 16
The Care GI-I is a 7-point Likert scale that the caregiver uses to rate improvement in overall seizure control, behavior, safety and tolerability after the initiation of study drug relative to Baseline (before treatment with the study drug). The participant will be rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). The parent/caregiver will complete the Care GI-I via interview. Higher score will indicate worse symptoms.
Baseline up to Week 16
Clinical Global Impression of Improvement (CGI-I) Score
Time Frame: Baseline up to Week 16
The CGI-I Clinician is a 7-point Likert scale that the investigator uses to rate a participant's change (improvement) in overall seizure control, behavior, safety and tolerability, after the initiation of study drug relative to Baseline (before treatment with the study drug). The participant will be rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.
Baseline up to Week 16
CGI-I Nonseizure Symptoms Score
Time Frame: Baseline up to Week 16
The CGI-I nonseizure symptoms instrument is a series of single-item assessments that the investigator uses to rate improvement in the symptoms and impacts in select nonseizure domains since initiating the study drug. The participant will be rated by the investigator on the 7-point scale as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.
Baseline up to Week 16
Change in Quality of Life Inventory-Disability (QI-Disability) Score
Time Frame: Baseline up to Week 16
The QI-Disability tool is a parent/caregiver-reported questionnaire that evaluates quality of life in children with intellectual disabilities. It contains 32 items covering 6 domains of quality of life: physical health, positive emotions, negative emotions, social interaction, leisure and the outdoors, and independence. Scores are from a 5-point Likert scale and then are transformed to a scale of 0 to 100. Possible scores range from 0-100, with higher scores indicating better quality of life.
Baseline up to Week 16
CGI-I Seizure Intensity and Duration Score
Time Frame: Baseline up to Week 16
The CGI-I Seizure Intensity and Duration instrument is used by the parent/caregiver to rate changes in intensity and/or duration of the most impactful seizures from the first assessment. The participant's symptoms will be rated on the 7-point scale as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.
Baseline up to Week 16
Percent Change From Baseline in Frequency of All Seizures per 28 Days During the Maintenance Period
Time Frame: Baseline up to Week 16
Seizure frequency per 28 days is defined as total number of seizures 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 the frequency of seizures per 28 days at Baseline multiplied by 100.
Baseline up to Week 16
Percent Change from Baseline in Frequency of All Seizures per 28 Days During the Full Treatment Period
Time Frame: Baseline up to Week 16
Seizure frequency per 28 days is defined as total number of seizures 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 full Treatment Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100.
Baseline up to Week 16
Percent Change from Baseline in MMD Seizure Frequency per 28 Days During the Maintenance Period
Time Frame: Baseline up to Week 16
MMD seizure frequency per 28 days is defined as total number of MMD seizures 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.
Baseline up to Week 16
Change From Baseline in Percentage of MMD Seizure-free Days
Time Frame: Baseline up to Week 16
MMD Seizure-free days will be defined as the number of days the participant remained MMD seizure free after initiation of the treatment.
Baseline up to Week 16
Longest MMD Seizure-free Interval
Time Frame: Baseline up to Week 16
Longest MMD Seizure-free Interval will be defined as the longest time period that the participant remained MMD seizure free after initiation of the treatment.
Baseline up to Week 16
Number of Days When Rescue Antiseizure Medication (ASM) is Used
Time Frame: Baseline up to Week 16
Baseline up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2021

Primary Completion (Actual)

January 25, 2024

Study Completion (Actual)

January 25, 2024

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TAK-935-3002
  • 2021-002481-40 (EudraCT Number)
  • jRCT2051210073 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lennox Gastaut Syndrome (LGS)

Clinical Trials on Soticlestat

3
Subscribe