Lennox Gastaut Syndrome (LGS)Phase 3NCT04938427
A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome
A Phase 3 study testing Soticlestat in people with Lennox Gastaut Syndrome (LGS), run by Takeda at 98 sites in 18 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 55 years
- Conditions the study is for
- Lennox Gastaut Syndrome (LGS)
- What is being tested?
- Soticlestat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 98 sitesin 18 countries
- Study dates
- 8 Nov 2021to 25 Jan 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Has documented clinical diagnosis of LGS.
- 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.
- Weighs ≥10 kg at the Screening Visit (Visit 1).
- 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).
- 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.)
- 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.
Who cannot join
- 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.
- 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.
- 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.
Trial locations and contacts
98 sites in 18 countries.
98 sites in 18 countries
United States24 sites
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, 30328
Midatlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Medical University of South Carolina Children Hospital - PIN
Charleston, South Carolina, 29425
Children's Hospital Colorado.
Denver, Colorado, 80218
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
Fort Worth, Texas, 76104
University of Iowa Hospitals & Clinics - (CRS)
Iowa City, Iowa, 52242
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey, 07039
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Premier Healthcare Inc.
New York, New York, 10001
NYU Comprehensive Epilepsy Center
New York, New York, 10016
Northwell Health Physician Partners - Neurology at Lenox Hill
New York, New York, 10075
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Oregon Health and Science University
Portland, Oregon, 97239
Minnesota Epilepsy Group PA
Roseville, Minnesota, 55113
University of Utah - Primary Children's Hospital - PPDS
Salt Lake City, Utah, 84113
University of California Benioff Children's Hospital
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98105
MultiCare Institute for Research & Innovation (Tacoma)
Tacoma, Washington, 98402
Center For Neurosciences
Tucson, Arizona, 85718
Pediatric Neurology PA
Winter Park, Florida, 32789
WellSpan Oncology Research
York, Pennsylvania, 17403
China12 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, 100045
The First Hospital of Jilin University
Changchun, Jilin, 130021
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, 510623
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, 330006
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200040
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518026
Wuhan Childrens hospital
Wuhan, Hubei, 430010
Japan11 sites
Fukuoka Children's Hospital
Fukuoka, Hukuoka, 813-0017
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo, 187-0031
Kumamoto-Ezuko Medical Center for The Severely Disabled
Kumamoto, Kumamoto, 862-0947
Aichi Medical University Hospital
Nagakute-Shi, Aiti, 480-1195
Yasuhara Childrens Clinic
Neyagawa, Osaka, 572-0085
National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata, Niigata, 950-2074
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
National Hospital Organization Nagasaki Medical Center
Omura-Shi, Nagasaki, 856-0835
Osaka City General Hospital
Osaka, Osaka, 534-0021
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, 420-0953
Osaka University Hospital
Suita-Shi, Osaka, 565-0871
France5 sites
CHRU Dijon Hopital General
Dijon, Cote-d'Or, 21079
Hopital Roger Salengro
Lille, Nord, 59000
Hopitaux de La Timone
Marseille, 13386
Hopital Necker - Enfants Malades
Paris, 75015
Hopital Robert Debre
Paris, 75019
Spain5 sites
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035
Hospital Regional Universitario de Malaga Hospital General
Málaga, 29010
Clinica Universidad Navarra
Pamplona, Navarre, 31008
Centro de Neurologia Avanzada
Seville, 41013
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Ukraine5 sites
Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
Dnipro, Dnipropetrovsk Oblast, 49100
Communal Non-profit Enterprise City Childrens Clinical Hospital #6 of DCC
Dnipro, Dnipropetrovsk Oblast, 49101
Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
Ivano-Frankivsk, 76018
CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
Kyiv, 4080
SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
Kyiv, 4209
Australia4 sites
Austin Hospital
Heidelberg, Victoria, 3084
Alfred Hospital
Melbourne, Victoria, 3004
Sydney Children's Hospital
Randwick, New South Wales, 2031
Queensland Childrens Hospital
South Brisbane, Queensland, 4101
Germany4 sites
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld, North Rhine-Westphalia, 33617
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, 60528
Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
Radeberg, Sachse, 1454
Schon Klinik Vogtareuth
Vogtareuth, Bavaria, 83569
Hungary4 sites
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Budapest, 1023
Bethesda Gyermekkorhaz
Budapest, 1143
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
Budapest, 1145
Pecsi Tudomanyegyetem
Pécs, Baranya, 7623
Italy4 sites
Ospedale Bellaria
Bologna, Emilia-Romagna, 40139
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany, 50139
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy, 27100
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 168
Serbia4 sites
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, 11000
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, 11000
University Clinical Center Nis
Niš, 18 000
Children and Youth Health Care Institute of Vojvodina
Novi Sad, 21 000
Belgium3 sites
Hopital Universitaire des Enfants Reine Fabiola
Brussels
UZ Antwerpen PIN
Edegem, Antwerpen, 2650
Centre Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Brabant Wallon, 1340
Canada3 sites
Alberta Childrens Hospital
Calgary, Alberta, T3B 6A8
Hospital For Sick Children
Toronto, Ontario, M5G 1X8
Child and Family Research Institute
Vancouver, British Columbia, V5Z 4H4
Greece3 sites
Attikon University General Hospital
Chaïdári, Attica, 124 62
University General Hospital of Larissa
Larissa, 411 10
Hippokration Hospital
Thessaloniki, 546 42
Poland3 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-355
Netherlands2 sites
Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE
Stichting Epilepsie Instellingen Nederland
Zwolle, Overijssel, 8025 BV
About this study
Official title: 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.
Read the 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):
- Soticlestat
- 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.
- Conditions
- Lennox Gastaut Syndrome (LGS)
- Being tested
- Placebo, Soticlestat
- Keywords
- Drug therapy
- Medical subject headings
- Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Soticlestat placebo-matching mini-tablets or tablets.
SoticlestatDrug
Also called TAK-935
Soticlestat mini-tablets or tablets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Soticlestat placebo-matching mini-tablets or tablets, orally or via G-tube or MIC-KEY button or J-tube, BID, up to 4 weeks during titration. Participants continued to receive soticlestat placebo-matching mini-tablets or tablets for 12 weeks during maintenance. The total duration of the treatment was up to 16 weeks (Full Treatment Period). Soticlestat matching tapering was done to maintain the blind if participants decided to discontinue the treatment. Receives: Drug: Placebo |
| Soticlestat | Experimental | Participants weighing <45 kg: Soticlestat, mini-tablets, at the dose of 40 mg to 200 mg, orally or via G-tube or MIC-KEY button or J-tube, BID based on body weight up to 4 weeks during titration. Participants continued to receive the dose that they were on at the end of the titration, for 12 weeks during maintenance. The total duration of the treatment was up to 16 weeks (Full Treatment Period) with the dose tapered down if participants decided 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 during titration. Participants continued to receive 300 mg BID for 12 weeks during maintenance. The total duration of the treatment was up to 16 weeks (Full Treatment Period) with the dose tapered down if participants decided to discontinue the treatment. Receives: Drug: Soticlestat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Full Treatment Period
MMD seizure frequency per 28 days was defined as the total number of MMD seizures reported during the period divided by the number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline was defined as (frequency of seizures per 28 days during the 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.
Measured: Baseline; Full Treatment Period: Weeks 1 to 16
Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Maintenance Period
MMD seizure frequency per 28 days was defined as the 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 was 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.
Measured: Baseline; Maintenance Period: Weeks 5 to 16
Secondary outcomes (13)
Percentage of Responders During the Maintenance Period
Responders are defined as those with ≥50% reduction from Baseline in MMD seizures during the Maintenance Period. Percentages are rounded off to the nearest single decimal place.
Measured: Maintenance Period: Weeks 5 to 16
Percentage of Responders During the Full Treatment Period
Responders are defined as those with ≥50% reduction from Baseline in MMD seizures during the Full Treatment Period. Percentages are rounded off to the nearest single decimal place.
Measured: Full Treatment Period: Weeks 1 to 16
Percentage of Participants With ≤0%, >0% to ≤25%, >25% to ≤50%, >50% to ≤75%, >75% to ≤100% Reduction in MMD Seizure During the Full Treatment Period
Percent reduction from Baseline (%) is defined as [(Full Treatment Period MMD Seizure Frequency - Baseline MMD Seizure Frequency) divided by Baseline MMD Seizure Frequency] multiplied by 100. Data is reported as reduction of ≤0%, >0% to ≤25%, >25% to ≤50%, >50% to ≤75%, >75% to ≤100% or more in seizures from Baseline. Percentages are rounded off to the nearest single decimal place.
Measured: Full Treatment Period: Weeks 1 to 16
Percentage of Participants With Caregiver Global Impression of Improvement (Care GI-I) Scale Responses as Per the Parent/Caregiver Reported Impression at Week 16
The Care GI-I is a 7-point Likert scale that the caregiver used 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 was 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 completed the Care GI-I via interview. Lower scores indicate improvement. Percentages are rounded off to the nearest single decimal place.
Measured: Week 16
Percentage of Participants With Clinical Global Impression of Improvement (CGI-I) Scale Responses as Per the Investigator Reported Impression at Week 16
The CGI-I (Clinician) is a 7-point Likert scale that the investigator 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 was 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 investigator or designee will complete the CGI-I. Lower scores indicate improvement. Percentages are rounded off to the nearest single decimal place.
Measured: Week 16
Percentage of Participants With CGI-I Nonseizure Symptoms Instrument Responses for Each Domain as Per the Investigator Reported Impression at Week 16
The CGI-I nonseizure symptoms instrument is a series of single-item assessments that the investigator used to rate improvement in the symptoms and impacts in select nonseizure domains (alertness, communication, and disruptive behaviors) since initiating the study drug. The participant was rated by the investigator for each domain 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). Lower scores indicated improvement. Data for percentage of participants categorized based on the responses for each domain are presented. Percentages are rounded off to the nearest single decimal place.
Measured: Week 16
Change From Baseline in Quality of Life Inventory-Disability (QI-Disability) Total Score at Week 16
The QI-Disability tool is a parent/caregiver-reported questionnaire evaluated the 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. Each QI-Disability item is rated on a Likert scale of: Never, Rarely, Sometimes, Often, and Very Often. Items were linearly transformed to a scale of 0 to 100, with higher scores representing better quality of life. Domain scores are calculated by averaging item scores. The domain scores are summed and divided by 6 to yield a total score. The total score ranges from 0 to 100, with higher scores indicating a better quality of life. A negative change from Baseline implies deteriorating quality of life. Mixed-effects model for repeated measures (MMRM) was used for analysis.
Measured: Baseline, Week 16
Percentage of Participants With CGI-I Seizure Intensity and Duration Instrument Responses as Per the Parent/Caregiver Reported Impression at Week 16
The CGI-I seizure intensity and duration instrument was 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 were 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). Lower scores indicate improvement. Percentages are rounded off to the nearest single decimal place.
Measured: Week 16
Percent Change From Baseline in Frequency of All Seizures Per 28 Days During the Maintenance Period
Seizure frequency per 28 days was defined as the total number of seizures reported during the period divided by the number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline was 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.
Measured: Baseline; Maintenance Period: Weeks 5 to 16
Percent Change From Baseline in Frequency of All Seizures Per 28 Days During the Full Treatment Period
Seizure frequency per 28 days was defined as the total number of seizures reported during the period divided by the number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline was defined as (frequency of seizures per 28 days during the 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.
Measured: Baseline; Full Treatment Period: Weeks 1 to 16
Change From Baseline in Percentage of MMD Seizure-free Days During the Full Treatment Period
MMD Seizure-free days was defined as the number of days the participant remained MMD seizure free after initiation of the treatment. The change from baseline in percentage of MMD seizure-free days, was defined as the percentage of seizure-free days during the Full Treatment Period minus the percentage of seizure-free days during the Baseline. A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.
Measured: Baseline up to Week 16
Longest MMD Seizure-free Interval During the Full Treatment Period
Longest MMD Seizure-free Interval was defined as the longest time period that the participant remained MMD seizure-free after initiation of the treatment. A linear model with treatment group and age stratum as factors was used for analysis.
Measured: Full Treatment Period: Weeks 1 to 16
Number of Days When Rescue Antiseizure Medication (ASM) is Used During the Full Treatment Period
Use of rescue ASM was recorded in the case report form (CRF) along with start and end date of medication. Based on
the start and end dates for all rescue ASMs taken by a participant, the number of days during the Full Treatment Period when rescue ASM was used was derived.
Measured: Full Treatment Period: Weeks 1 to 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start8 Nov 2021
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lennox Gastaut Syndrome (LGS)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938427
- Sponsor's protocol ID
- TAK-935-3002
- Other IDs
- 2021-002481-40, jRCT2051210073
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2021
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.