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Soticlestat for Lennox-Gastaut 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 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

Must not have

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)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up full treatment period: weeks 1 to 16

Awards & highlights

Pivotal Trial

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been hospitalized and intubated for severe seizures twice in the last 3 months.

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I do not have any major health issues that could affect my participation in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; full treatment period: weeks 1 to 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; full treatment period: weeks 1 to 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; full treatment period: weeks 1 to 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change From Baseline in Percentage of MMD Seizure-free Days During the Full Treatment Period

Change From Baseline in Quality of Life Inventory-Disability (QI-Disability) Total Score at Week 16

Longest MMD Seizure-free Interval During the Full Treatment Period

+10 more

Side effects data

From 2024 Phase 3 trial • 270 Patients • NCT04938427

14%

Somnolence

13%

Change in seizure presentation

Upper respiratory tract infection

Nasopharyngitis

Pyrexia

Decreased appetite

Fatigue

COVID-19

Constipation

Fall

Diarrhoea

Cataract

Status epilepticus

Urinary tract infection

Influenza

Oxygen saturation decreased

Pneumonia

Vomiting

Pyelonephritis

COVID-19 pneumonia

Acute respiratory failure

Rhinovirus infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Soticlestat

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 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.

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 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Soticlestat

2022

Completed Phase 3

~640

0 / 5Eligibility criteria met