Trial intelligence / Profile preview

Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures

NCT05473442Phase 2

Key facts

Status
Terminated
Start
Dec 2022
Primary completion
Jul 2023
Countries
2
Modality
Small Molecules
Conditions
focal onset seizure
01

Overview

Phase 2, randomised, double-blind trial of ivermectin in focal onset seizure (3 arms), sponsored by Equilibre Biopharmaceuticals. Primary endpoint: Median percentage change in the overall number of countable observable seizures. Started Dec 2022; status: terminated.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • EQU-001 60 mg

    Ivermectin 60 mg daily + Standard of Care ASMs

  • EQU-001 20 mg

    Ivermectin 20 mg daily + Standard of Care ASMs

  • Placebo

    Matching Placebo + Standard of Care ASMs

03

Who it enrols

Adults with focal epilepsy according to ILAE 2017 criteria who have uncontrolled seizures despite treatment with 1-3 stable anti-seizure medications.

04

Endpoints

Primary

  • Median percentage change in the overall number of countable observable seizures

Secondary

  • Median percentage change in the overall number of countable observable seizures

  • >= 50% responder rates

  • Patient's Global Impression of Change

  • Percent (%) of subjects who are seizure free

  • >= 70% and >= 90% response rates

  • Patient weighted Quality of Life in Epilepsy (QOLIE 31-P) scale score

  • Number of adverse events (CTCAE grade 2 or higher)

  • Columbia-Suicide Severity Rating Scale

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