An Open-label, Non-randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504104-29-00

Acronym

TAK-935-3004

Enrollment

Registered

2023-11-14

Start date

2024-04-15

Completion date

2024-08-14

Last updated

2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dravet Syndrome/Lennox-Gastaut Syndrome

Brief summary

Percent change from baseline in convulsive (DS) and MMD (LGS) seizure frequency per 28 days during the initial 12 weeks of the maintenance period.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in convulsive (DS) and MMD (LGS) seizure frequency per 28 days during the initial 12 weeks of the maintenance period.	—

Countries

Denmark

Outcome results