TerminatedPhase 3

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

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-935-3003 study is no longer necessary. Therefore, Takeda has made a decision to close this study

United States352 participantsStarted 2022-03-04

Plain-language summary

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.

Who can participate

Age range2 Years – 56 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.

Exclusion criteria

✕. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
✕. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) \>450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF.
✕. Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.

What they're measuring

Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)

Timeframe: Up to 4 years

Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Timeframe: Up to 4 years

Change from Baseline in Body Weight for All Age Groups

Timeframe: Up to 4 years

Change from Baseline in Height for All Age Groups

Timeframe: Up to 4 years

Absolute Value for Tanner Stage for Children 6 to 17 Years of Age During the Study

Timeframe: Up to 4 years

Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study

Timeframe: Up to 4 years

Trial details

NCT IDNCT05163314

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-24

View on ClinicalTrials.gov More Dravet Syndrome (DS) trials

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

United States352 participantsStarted 2022-03-04

Plain-language summary

Who can participate

Age range2 Years – 56 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.

Exclusion criteria

✕. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
✕. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) \>450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF.
✕. Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.

What they're measuring

Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)

Timeframe: Up to 4 years

Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Timeframe: Up to 4 years

Change from Baseline in Body Weight for All Age Groups

Timeframe: Up to 4 years

Change from Baseline in Height for All Age Groups

Timeframe: Up to 4 years

Absolute Value for Tanner Stage for Children 6 to 17 Years of Age During the Study

Timeframe: Up to 4 years

Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study

Timeframe: Up to 4 years