Phase 2 Epilepsy Trial, Terminated NCT03635073 Sponsor: Takeda Condition: Epilepsy
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03635073) enrolled 156 participants who were given a study medicine called soticlestat. The trial was measuring a range of things, including how often participants experienced unexpected medical events (called adverse events) while taking the medicine, changes in behaviour and everyday living skills (using two questionnaires — the Vineland Adaptive Behavior Scale and the Aberrant Behavior Checklist), thoughts of self-harm (using a standard rating scale), and changes in certain blood test results. The reported data shows that none of the 156 participants were recorded as having "completed" the study, with all 156 listed under "not completed" — no further explanation for this was provided in the submitted data. The reported data shows that 91% of participants experienced at least one adverse event (an unexpected medical occurrence) during the study. On the behaviour questionnaire for participants aged 6 and over (ABC-C), the average total score at the start of the study was 36.8 out of a possible 174, and the average change from that starting point was −16.3 points, where a negative number indicates a reduction in the scores being measured. Changes were also reported across individual sections of both behaviour questionnaires and across everyday living skill categories; these ranged from small negative numbers (indicating reductions in the scores being tracked) to small positive numbers, depending on the specific area measured. For the blood test results and the self-harm rating scale, numbers were reported for individual categories, though the submitted data did not include a summary explanation linking those numbers to an overall conclusion. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Epilepsy Trial, Terminated

NCT03635073
Terminated Phase 2 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You must have already taken part in a previous clinical study of soticlestat, and either completed that study fully, or received at least 10 weeks of the study drug in a placebo-controlled study without experiencing a serious or severe side effect linked to the drug.
  • In the opinion of the doctor running the trial, you may personally benefit from taking soticlestat.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have a significant health condition that, in the doctor's opinion, would make it unsafe for you to take part in the study.
  • You have taken part in another clinical trial involving an experimental drug, device, or treatment in the last 90 days (unless that trial also involved soticlestat).
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study or within 30 days of taking your last dose of the study drug.
  • You have attempted suicide in the last year, are considered to be at significant risk of suicide, or have expressed certain thoughts of suicide as measured by a standard assessment tool used at screening (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 17 August 2026

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Trial contact details on record

Australian sites

Monash Children's Hospital, Clayton, Victoria
Austin Hospital, Heidelberg, Victoria
Austin Hospital, Heidelberg West, Victoria

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
19 July 2018
Est. completion
30 July 2025

Where this trial was run

🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇮🇱 Israel 🇵🇱 Poland 🇵🇹 Portugal 🇪🇸 Spain 🇺🇸 United States

These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE); Change From Baseline in Behavioral and Adaptive Functional Measures Using the Vineland Adaptive Behavior Scale (VABS); Change From Baseline in Behavior Measures Using Total Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age; Change From Baseline in Behavior Measures Using Subscale Scores of the Aberrant Behavior Checklist-Community Edition (ABC-C) for Participants Greater Than Equal to (≥) 6 Years of Age; Number of Participant...

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 17 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov