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Soticlestat for Rare Epilepsies (Endymion 1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and effective when used with other anti-seizure drugs. Participants will take the drug twice a day and visit the clinic every few months. The study will continue as long as the participant benefits from the drug.

Who is the study for?

This trial is for adults and children with rare epilepsies who have previously participated in a soticlestat study. They must not have had serious side effects related to the drug, should be potentially benefiting from it, and cannot be pregnant or breastfeeding. Those with significant diseases or recent suicidal attempts are excluded.

What is being tested?

The trial is testing the long-term safety of Soticlestat when taken alongside other anti-seizure medications. Participants will take Soticlestat twice daily and visit the clinic every 2-6 months for as long as they benefit from the treatment.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to ensure that Soticlestat remains safe and tolerable over an extended period when combined with their current seizure treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS)

Percentage of Participants Who Experience At least one Adverse Event (AE)

Secondary study objectives

Change from Baseline in Clinician's Clinical Global Impression of Severity (CGI-S)

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

Vomiting

Oxygen saturation decreased

Influenza

Cataract

Pneumonia

Urinary tract infection

Status epilepticus

Pyelonephritis

COVID-19 pneumonia

Acute respiratory failure

Rhinovirus infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Soticlestat

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SoticlestatExperimental Treatment1 Intervention

Treatment: Soticlestat, tablets orally twice daily at optimized dose, titrated in up to 2 weeks of Dose Optimization Period, followed by Maintenance Period, which lasts until development is stopped by the sponsor, or the product is approved for marketing, or at any time at the discretion of the sponsor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Soticlestat

2022

Completed Phase 3

~640

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