NCT05473442

Study of EQU-001 for Uncontrolled Focal Onset Seizures

A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Equilibre Biopharmaceuticals B.V. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Focal Onset Seizures

Interventions

Type	Name	Description
DRUG	EQU-001	20 mg pills of EQU-001
OTHER	Matching Placebo	20 mg matching placebo pills

Timeline

• Start date: 2022-12-27
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2022-07-26
• Last updated: 2023-12-21

Locations

13 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study