Soticlestat for Rare Epilepsies
(Endymion 1 Trial)
Recruiting at 68 trial locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Takeda
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study. Study treatments may continue as long as the participant is receiving benefit from it.
Eligibility Criteria
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.Inclusion Criteria
Participants must have participated in a previous soticlestat study and meet one of the following conditions: Successfully completed a soticlestat clinical study, Received at least 10 weeks of treatment with the study drug in an antecedent placebo-controlled blinded soticlestat clinical study and the participant did not have a serious or severe AE that, in the investigator's or sponsor's opinion, was related to the study drug and would make it unsafe for the participant to continue receiving the study drug, In the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat
Exclusion Criteria
Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as 'yes' to suicidal ideation question 4 or 5 on the C-SSRS at Screening) or appearing suicidal per investigator judgment
My doctor thinks my condition makes me unfit for this study.
Participant is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
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Treatment Details
Interventions
- Soticlestat (Unknown)
- TAK-935 (Unknown)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier