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NCT05473442Phase 2
Key facts
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.
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
Adults with focal epilepsy according to ILAE 2017 criteria who have uncontrolled seizures despite treatment with 1-3 stable anti-seizure medications.
Median percentage change in the overall number of countable observable seizures
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
Beyond the preview
Full results, competitive context and analysis are in the Gosset platform.
Available in the Gosset platform where reported.
Available in the Gosset platform where reported.
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