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Soticlestat for Dravet Syndrome

Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has documented clinical diagnosis of DS
Weighs ≥10 kg at the screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 16
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help reduce the number of seizures people with DS have.

Who is the study for?
This trial is for children and young adults with Dravet Syndrome who weigh at least 10 kg. They should have had a minimum of 12 convulsive seizures in the past 12 weeks, be on stable doses of up to four antiseizure medications, and not have any other unstable health conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial tests if Soticlestat can reduce seizure frequency when added to standard therapy compared to a placebo. Participants will take either Soticlestat or placebo alongside their regular antiseizure drugs for 16 weeks, with an option to join an extension study afterwards.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience unexpected reactions due to adding Soticlestat or placebo to their current treatment regimen. These could range from mild discomforts like headaches or nausea to more serious issues depending on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Down syndrome.
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I weigh at least 10 kg.
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My seizures are not controlled despite trying at least one antiseizure medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Convulsive Seizures
Percent Change From Baseline in Convulsive 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 more

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT03694275
25%
Seizure
25%
Lethargy
25%
Fatigue
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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SoticlestatExperimental Treatment1 Intervention
Participants weighing <45kg: Soticlestat, mini-tablets, at the dose of 40mg to 200mg, 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 the body weight up to 4 weeks in Titration Period. Participants will continue to receive dose that they are on at the end of Titration Period, for 12 weeks in Maintenance Period. The total duration of the treatment will be up to 16 weeks (Treatment Period). The dose will be tapered down if participants decide to discontinue the treatment. Participants weighing ≥45kg: Soticlestat mini-tablets or tablets with a starting dose of 100mg BID followed by 200 mg BID and, then 300mg BID, up to 4 weeks in Titration Period. Participants will continue to receive 300mg BID for 12 weeks in the Maintenance Period. The total duration of the treatment will be up to 16 weeks (Treatment Period). The 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. 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
~490

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,198 Previous Clinical Trials
4,178,209 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,202 Previous Clinical Trials
489,488 Total Patients Enrolled

Media Library

Soticlestat Clinical Trial Eligibility Overview. Trial Name: NCT04940624 — Phase 3
Dravet Syndrome Research Study Groups: Soticlestat, Placebo
Dravet Syndrome Clinical Trial 2023: Soticlestat Highlights & Side Effects. Trial Name: NCT04940624 — Phase 3
Soticlestat 2023 Treatment Timeline for Medical Study. Trial Name: NCT04940624 — Phase 3

Frequently Asked Questions

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

Is this trial limited to a particular age group?

"According to the age requirements set out by the researchers conducting this clinical trial, the youngest a patient can be is 2 years old whereas the oldest a patient can be is 21 years old."

Answered by AI

Has Soticlestat been cleared by the FDA?

"Soticlestat has received a safety score of 3. This assessment comes from a Phase 3 trial, where there is both some evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

How many different sites are coordinating this trial?

"To limit travel as a burden, it is recommended to choose a clinical trial site that is close to your location from the 21 options. A few of the locations recruiting patients are Fort Worth, Gulf Breeze and Columbus."

Answered by AI

Could you explain the requirements for volunteers for this experiment?

"This clinical trial is reserved for patients that suffer from epilepsies and myoclonic seizures. The ages of the patients should fall between 2 and 21. In total, 142 people can be admitted into the study."

Answered by AI

Are new participants being accepted for this experiment currently?

"The study is ongoing and actively recruiting patients, as reflected in the clinicaltrials.gov listing which was last updated on 10/13/2022."

Answered by AI

How many enrollees are allowed in this clinical trial?

"That is accurate. The clinical trial is currently ongoing, as per the information available on clinicaltrials.gov. The study began enrolling patients on 10/28/2021 and the most recent update was on 10/13/2022. A total of 142 patients are being recruited from 21 different locations."

Answered by AI
~0 spots leftby Apr 2024