drugset / Trial / NCT05473442

Study of EQU-001 for Uncontrolled Focal Onset Seizures

NCT05473442 ↗

Phase 2 Terminated 27 enrolled Equilibre Biopharmaceuticals B.V.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a Phase 2 multinational, double-blind, placebo-controlled, randomized (1:1:1), efficacy and safety study of adjunctive EQU-001 for the treatment of focal onset seizures in subjects aged 18 to 65 years, who have been diagnosed with epilepsy according to International League Against Epilepsy (ILAE) Classification of the Epilepsies 2017 criteria This study is designed to test the efficacy and safety of EQU-001 20 mg and 60 mg as compared with placebo as an add-on anti-seizure medication (ASM) in subjects with uncontrolled focal onset seizures. The treatment portion of the study will be comprised of a 4-week double-blind medication activation period and a 12-week double-blind maintenance period.

Timeline

Start
2022-12-27
Primary completion
2023-07-01
Completion
2023-07-01

Outcome

Outcome not reported

Stopped (Business): “insufficient funding to complete the study”

Drugs

EvaluationDrugModalityDoseRoute
Subject EQU-001 Unknown 20 mg —

Indications