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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

Endymion 1 Trial 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.Check my eligibility

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.See study design

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.

Endymion 1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Behavior Measures Using Total Scores and Subscale Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants ≥6 Years of age

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

Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Categorization Based on Columbia Classification Algorithm of Suicide Assessment Categories 1,2,3,4, and 5 for Participants ≥6 Years of age

+1 more

Secondary outcome measures

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

Percent Change from Baseline in Convulsive Seizure 28-day Frequency (Dravet syndrome [DS] Participants)

Percent Change from Baseline in Drop Seizure 28-day Frequency (Lennox-Gastaut syndrome [LGS] Participants)

+2 more

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT03694275

25%

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%

Study treatment Arm

Soticlestat Dup15q

Soticlestat CDD

Endymion 1 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

~490

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,178,106 Total Patients Enrolled

5 Trials studying Epilepsy

260 Patients Enrolled for Epilepsy

Media Library

Soticlestat (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT03635073 — Phase 2

Epilepsy Research Study Groups: Soticlestat

Epilepsy Clinical Trial 2023: Soticlestat Highlights & Side Effects. Trial Name: NCT03635073 — Phase 2

Soticlestat (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03635073 — Phase 2

Frequently Asked Questions

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

Could you provide a comprehensive list of the institutions that are running this clinical research within America?

"Medsol Clinical Research Center, Inc. in Port Charlotte, Mayo Clinic - PPDS in Rochester and Bluegrass Epilepsy Reseach from Lexington are amongst the 33 medical centers that are recruiting participants for this experiment."

Answered by AI

Are recruitment efforts currently underway for this research project?

"The clinicaltrial.gov database reveals that this medical study is no longer recruiting participants, having last been updated on 9th May 2022. Despite this trial not being open to new patients, there are 1611 other studies accepting enrollees at the present time."

Answered by AI

Does this medical study include individuals of a younger age bracket?

"According to the enrollment rules, this clinical trial is available for individuals between 2 and 65 years of age. Participants who are younger than 18 or older than 65 can find 468 and 1131 trials respectively that match their criteria."

Answered by AI

To whom is this trial open for enrollment?

"In order to be eligible for the clinical trial, potential participants must possess aura symptoms and fall between ages 2 and 65. There is a total of 156 openings available."

Answered by AI