TerminatedPhase 3

A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

Stopped: Business decision unrelated to patient safety.

Denmark1 participantsStarted 2024-04-25

Plain-language summary

The purpose of this study is to check how soticlestat impacts symptoms of Dravet syndrome \[DS\] and Lennox-Gastaut syndrome \[LGS\] in participants who have been exposed to fenfluramine.

Who can participate

Age range2 Years – 65 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

✓. The participant has been exposed to fenfluramine (currently on or used previously).
✓. The participant has a clinical diagnosis of LGS and a history of, on average, ≥12 MMD seizures in the last 90 days immediately before screening based on historical information, and the participant has ≥4 MMD seizures during a minimum of 4 weeks of seizure data collection during the prospective baseline period.
✓. The participant is currently taking 0 to 5 antiseizure treatments (eg. antiseizure medications \[ASMs\], vagus nerve stimulation \[VNS\], ketogenic diet) at stable doses.

Exclusion criteria

✕. The participant is currently enrolled in a clinical study involving an investigational product or treatment device (ie, not approved in that country, other than soticlestat), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Note: Compatibility will be determined on the basis of consultation with the sponsor/designee.
✕. The participant has a known hypersensitivity to any component of the soticlestat formulation.
✕. Participants aged ≥6 years who have positive answers on item numbers 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) before dosing are excluded. This scale will only be administered to participants aged ≥6 years at the time of enrollment or participants who turn 6 after enrollment.

What they're measuring

Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During First 12 Weeks of Maintenance Period for DS Participants

Timeframe: Baseline to Week 12 of Maintenance Period

Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During First 12 Weeks of Maintenance Period for LGS Participants

Timeframe: Baseline to Week 12 of Maintenance Period

Trial details

NCT IDNCT06422377

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-14

Results submitted2025-02-14

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

Who can participate

Age range2 Years – 65 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

✓. The participant has been exposed to fenfluramine (currently on or used previously).
✓. The participant has a clinical diagnosis of LGS and a history of, on average, ≥12 MMD seizures in the last 90 days immediately before screening based on historical information, and the participant has ≥4 MMD seizures during a minimum of 4 weeks of seizure data collection during the prospective baseline period.
✓. The participant is currently taking 0 to 5 antiseizure treatments (eg. antiseizure medications \[ASMs\], vagus nerve stimulation \[VNS\], ketogenic diet) at stable doses.

Exclusion criteria

✕. The participant is currently enrolled in a clinical study involving an investigational product or treatment device (ie, not approved in that country, other than soticlestat), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Note: Compatibility will be determined on the basis of consultation with the sponsor/designee.
✕. The participant has a known hypersensitivity to any component of the soticlestat formulation.
✕. Participants aged ≥6 years who have positive answers on item numbers 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) before dosing are excluded. This scale will only be administered to participants aged ≥6 years at the time of enrollment or participants who turn 6 after enrollment.

What they're measuring

Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During First 12 Weeks of Maintenance Period for DS Participants

Timeframe: Baseline to Week 12 of Maintenance Period

Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During First 12 Weeks of Maintenance Period for LGS Participants

Timeframe: Baseline to Week 12 of Maintenance Period