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NCT03635073 · ClinicalTrials.gov registry record · Phase 2

A Study of Soticlestat in Adults and Children With Rare Epilepsies

A Phase 2 study, sponsored by Takeda.

Terminated
Registry status
Phase 2
Development phase
156
Enrollment target

NCT03635073: Clinical Trial Phase 2 study, sponsored by Takeda.

NCT03635073 is a Phase 2 study that was terminated before completion, run by Takeda. The registered enrollment target is 156 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03635073, a Phase 2 study, was terminated before completion, sponsored by Takeda.

TERMINATED
Registry status
Phase 2
Development phase
156 participants
Enrollment target

Study Summary

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.

Primary Outcome

An Adverse Event (AE) was defined any untoward medical occurrence in a subject or clinical study subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign vital sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to this medicinal product. A TEAE is defined as any AE that starts or increases in severity during or after

Interventions

  • DRUG Soticlestat

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2018-07-19
Est. Completion 2025-07-30
Phase Phase 2
Takeda

408 total trials

Why NCT03635073 stopped before completion

NCT03635073 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).

The record links to 0 conditions, and to 1 intervention - of which Soticlestat is the first listed.

NCT03635073 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03635073 about?

NCT03635073 is a clinical study titled "A Study of Soticlestat in Adults and Children With Rare Epilepsies". 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...

What is the current status of trial NCT03635073?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2018-07-19. Estimated completion is 2025-07-30.

What interventions are being tested in trial NCT03635073?

The interventions under investigation include: Soticlestat (DRUG).

Who is sponsoring clinical trial NCT03635073?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03635073's enrollment target sits among peer trials

156 445th of 2000 higher than 1,553 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03635073, the US trial registry maintained by the National Library of Medicine. NCT03635073 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.