TerminatedPhase 2

A Study of Soticlestat in Adults and Children With Rare Epilepsies

Stopped: Due to negative results from phase 3 SKYLINE and SKYWAY studies and unrelated to patient safety it has been determined that supplementary data from TAK-935-18-001 study is no longer necessary. Therefore, Takeda has made a decision to close this study

United States156 participantsStarted 2018-07-19

Plain-language 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.

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must have participated in a previous soticlestat study and meet one of the following conditions:
✓. In the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat

Exclusion criteria

✕. Clinically significant disease, that, in the investigator's opinion, precludes study participation.
✕. Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving Soticlestat).
✕. 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.
✕. 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.

What they're measuring

Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE)

Timeframe: From screening up to end of the study (up to approximately 84 months)

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

Timeframe: Baseline, Week 338

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

Timeframe: Baseline, Week 338

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

Timeframe: Baseline, Week 338

Number of Participants With Changes 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

Timeframe: Baseline, Week 338

Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Grams Per Liter (g/L))

Timeframe: Baseline, Week 338

Trial details

NCT IDNCT03635073

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-30

Results submitted2026-01-20

View on ClinicalTrials.gov More Epilepsy trials

A Study of Soticlestat in Adults and Children With Rare Epilepsies

United States156 participantsStarted 2018-07-19

Plain-language summary

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must have participated in a previous soticlestat study and meet one of the following conditions:
✓. In the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat

Exclusion criteria

✕. Clinically significant disease, that, in the investigator's opinion, precludes study participation.
✕. Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving Soticlestat).
✕. 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.
✕. 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.

What they're measuring

Percentage of Participants Who Experienced At Least One Treatment-emergent Adverse Event (AE)

Timeframe: From screening up to end of the study (up to approximately 84 months)

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

Timeframe: Baseline, Week 338

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

Timeframe: Baseline, Week 338

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

Timeframe: Baseline, Week 338

Change From Baseline in Clinical Laboratory Parameters: Serum Chemistry (Grams Per Liter (g/L))

Timeframe: Baseline, Week 338