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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has documented clinical diagnosis of LGS
Has had ≥8 MMD seizures each month in the 3 months prior to Screening and has had ≥8 MMD seizures per 28 days during the 4 to 6 week prospective Baseline Period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 16
Awards & highlights
Study Summary
This trial is testing a new drug, soticlestat, to see if it can reduce seizures in people with Lennox-Gastaut Syndrome when taken alongside other seizure medications.
Who is the study for?
This trial is for children, teenagers, and adults with Lennox-Gastaut Syndrome (LGS) who weigh at least 10 kg. They must have had a certain number of seizures despite trying at least one antiseizure medication (ASM), be on stable ASM doses or standard care treatments including specific cannabidiols, and not be at high risk of suicide or have other health conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests if Soticlestat can reduce major motor drop seizures when added to standard seizure therapies in LGS patients. Participants will receive either Soticlestat or a placebo alongside their regular treatment for 16 weeks, followed by dose reduction and a follow-up period.See study design
What are the potential side effects?
While the side effects are not explicitly listed here, participants will be closely monitored for any adverse reactions to Soticlestat since it's being studied for safety in combination with other therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Lennox-Gastaut syndrome.
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I've had 8 or more seizures per month for the last 3 months.
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I weigh at least 10 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Full Treatment Period
Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Maintenance Period (EMA Region Specific)
Secondary outcome measures
CGI-I Nonseizure Symptoms Score
CGI-I Seizure Intensity and Duration Score
Caregiver Global Impression of Improvement (Care GI-I) Score
+11 moreSide effects data
From 2020 Phase 2 trial • 20 Patients • NCT0369427525%
Seizure
25%
Fatigue
25%
Lethargy
13%
Agitation
13%
Apnoea
13%
Anaphylactic reaction
13%
Eosinophilia
13%
Hypotonia
13%
Diarrhoea
13%
Hypersomnia
13%
Sinusitis
13%
Upper respiratory tract infection
13%
Face injury
13%
Fall
13%
Activated partial thromboplastin time prolonged
13%
Anticonvulsant drug level increased
13%
International normalised ratio increased
13%
Balance disorder
13%
Drooling
13%
Rash
13%
Pruritus
13%
Pain
13%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Soticlestat Dup15q
Soticlestat CDD
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SoticlestatExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soticlestat
2022
Completed Phase 3
~640
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,206 Previous Clinical Trials
4,187,799 Total Patients Enrolled
5 Trials studying Lennox Gastaut Syndrome
1,047 Patients Enrolled for Lennox Gastaut Syndrome
Study DirectorStudy DirectorTakeda
1,215 Previous Clinical Trials
499,344 Total Patients Enrolled
3 Trials studying Lennox Gastaut Syndrome
750 Patients Enrolled for Lennox Gastaut Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been taking the same dose of CBD from the same maker for at least 4 weeks.I have been diagnosed with Lennox-Gastaut syndrome.My seizures are not controlled despite trying at least one antiseizure medication.I am not at risk of harming myself or others and haven't attempted suicide in the last year.I am on up to 3 stable seizure medications, including Fenfluramine or Epidiolex, for the last 4 weeks.I weigh at least 10 kg.I do not have any major health issues that could affect my participation in the study.I have been hospitalized and intubated for severe seizures twice in the last 3 months.I've had 8 or more seizures per month for the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Soticlestat
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cut-off for how many participants can join this research project?
"The sponsor, Takeda, needs to recruit 234 eligible participants from various locations in order to proceed with the study. For example, Nationwide Children's Hospital in Columbus, Ohio and Sunrise Pediatric Neurology in Marietta, Georgia are both participating."
Answered by AI
Are people of all ages being accepted into this research project?
"The age range this study is recruiting for is older than 2 and under 55 years old."
Answered by AI
What are the most common side effects associated with Soticlestat?
"Soticlestat is a Phase 3 trial drug, meaning that there is evidence of its efficacy and multiple rounds of data supporting its safety. Consequently, our team at Power estimates its safety to be a 3."
Answered by AI
Which type of person is this research project looking for?
"This trial is looking for 234 participants with lennox gastaut syndrome (lgs) between the ages of 2 and 55. Most importantly, patients must meet the following criteria: Has documented clinical diagnosis of LGS., 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); Fenflur"
Answered by AI
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