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Soticlestat for Dravet Syndrome

Phase 3
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing if a new drug, soticlestat, can help reduce seizures in children and adults with Dravet Syndrome or Lennox-Gastaut Syndrome.

Who is the study for?
This trial is for children and adults with Dravet Syndrome or Lennox-Gastaut Syndrome who were in a phase 3 soticlestat study. They must not have significant heart rhythm issues, be at risk of suicide, or have other serious health problems that could affect the study.Check my eligibility
What is being tested?
The trial tests if adding soticlestat to standard seizure treatments helps reduce seizures in patients with Dravet or Lennox-Gastaut Syndromes. Participants will take soticlestat tablets alongside their usual medication and attend regular visits.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience adverse reactions related to soticlestat on top of their current anti-seizure medications. These will be monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study
Absolute Value for Tanner Stage for Children 6 to 17 Years of Age During the Study
Change from Baseline in Body Weight for All Age Groups
+3 more
Secondary outcome measures
CGI-I Nonseizure Symptoms Score
CGI-I Seizure Intensity and Duration Score
Caregiver Global Impression of Improvement (Care GI-I) Score
+5 more

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT03694275
25%
Fatigue
25%
Seizure
25%
Lethargy
13%
Eosinophilia
13%
Diarrhoea
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%
Hypersomnia
13%
Hypotonia
13%
Agitation
13%
Apnoea
13%
Rash
13%
Pruritus
13%
Anaphylactic reaction
13%
Pain
13%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Soticlestat Dup15q
Soticlestat CDD

Trial Design

1Treatment groups
Experimental Treatment
Group I: SoticlestatExperimental Treatment1 Intervention
Participants with DS and LGS will receive:Participants weighing <45kg:Soticlestat,mini-tablets,titrated from lower dose level(60mg to 140mg) to higher dose(100mg to 200mg) twice daily(BID),based on body weight,orally/via enteral feeding tubes including but not limited to nasogastric(NG)-tube,gastrostomy tube(G-tube),MIC-KEY button,upto 2 weeks in Titration Period. Will continue to receive dose they are on at end of Titration Period,for approximately 4 years in Maintenance Period.Dose will be tapered down to lower dose(not less than lowest dose level based on weight)every 3 days until study drug is discontinued(upto 1week) in Taper Period.Participants weighing ≥45kg/adults:Soticlestat mini-tablets/tablets with starting dose of 200mg BID followed by 300mg BID,up to 2 weeks in Titration Period.Will continue to receive 300mg BID for approximately 4 years in Maintenance Period.Dose will be tapered down upto 100mg every 3 days until study drug is discontinued(up to 1 week) in Taper Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soticlestat
2022
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,200 Previous Clinical Trials
4,177,746 Total Patients Enrolled
4 Trials studying Lennox Gastaut Syndrome
817 Patients Enrolled for Lennox Gastaut Syndrome
Study DirectorStudy DirectorTakeda
1,203 Previous Clinical Trials
489,179 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
520 Patients Enrolled for Lennox Gastaut Syndrome

Media Library

Soticlestat Clinical Trial Eligibility Overview. Trial Name: NCT05163314 — Phase 3
Lennox Gastaut Syndrome Research Study Groups: Soticlestat
Lennox Gastaut Syndrome Clinical Trial 2023: Soticlestat Highlights & Side Effects. Trial Name: NCT05163314 — Phase 3
Soticlestat 2023 Treatment Timeline for Medical Study. Trial Name: NCT05163314 — Phase 3
Lennox Gastaut Syndrome Patient Testimony for trial: Trial Name: NCT05163314 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential harmful effects of Soticlestat?

"Soticlestat has undergone multiple rounds of testing and there is some efficacy data, so it received a score of 3."

Answered by AI

How many people are being given the chance to participate in this research?

"That is correct, the clinical trial is currently underway with a goal of 376 patients from 22 different centres. The data on clinicaltrials.gov show that the study was first posted on March 4th, 2022 and edited April 4th, 2022."

Answered by AI

What are the goals of this clinical trial?

"The purpose of this long-term study is to assess the changes in body weight for children aged 10-17 years old. Additionally, CGI-I Seizure Intensity and Duration Score, Clinical Global Impression of Improvement (CGI-I) Score, and Caregiver Global Impression of Improvement (Care GI-I) Score will be used as secondary measures over the course of 4 years."

Answered by AI

Does this research project have an age limit for participants?

"Adults aged 2 to 36 years old can enroll in this trial. There are a total of 389 studies for people under 18 and 1034 for patients 65 and older."

Answered by AI

Is this test phase of the research still recruiting more participants?

"Yes, this study is still open and looking for participants. The listing on clinicaltrials.gov shows that the posting was created on March 4th, 2022 and last updated April 4th of the same year."

Answered by AI

Who does this clinical trial hope to enroll?

"As indicated by the parameters set out on this clinical trial, individuals with lennox gastaut syndrome (LGS) between the ages of 2 and 36 may be eligible to participate. Up to 376 patients are needed for the study."

Answered by AI

Where can I find a medical facility that is running this trial?

"In addition to other locations, this trial is accepting patients at Midatlantic Epilepsy and Sleep Center in Bethesda, Maryland, Oregon Health and Science University in Portland, Oregon, and David Geffen School of Medicine at UCLA in Los Angeles, California."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
What site did they apply to?
Phoenix Childrens Hospital
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Paid clinical trial.
PatientReceived no prior treatments
~200 spots leftby May 2026