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NCT03635073

NCT03635073
Terminated Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • 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:

  • 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.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

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

Where this trial is recruiting

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

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

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...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov