Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
EQU-001 for Seizures in Adults with Epilepsy
NCT05063877Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2021
- Primary completion
- Oct 2022
- Countries
- 2
- Sponsor
- Equilibre Biopharmaceuticals
- Modality
- Small Molecules
- Drugs
- equ-001
- Conditions
- epilepsy
01
Overview
Phase 2, randomised, double-blind trial in epilepsy comparing Placebo Arm with EQU-001 Arm (2 arms). Primary endpoint: Treatment-Related Adverse Events (Grade 2 or higher) at 84 days. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo Arm
Matches EQU-001 dosing
EQU-001 Arm
Dose cohorts: 10 mg, 20 mg, 40 mg, 60 mg
03
Who it enrols
Adults (18-60) with epilepsy diagnosed per ILAE 2017 criteria, having uncontrolled countable seizures on 1-4 concomitant AEDs. Must not have a history of hypersensitivity to ivermectin or recent ivermectin use.
04
Endpoints
Primary
Treatment-Related Adverse Events (Grade 2 or higher)
Secondary
Change in Columbia-Suicide Severity Rating Scale responses
Median change in the number of countable seizures
Median change in generalized tonic-clonic and focal to generalized tonic-clonic seizures
Percent of subjects who are seizure free
Number of subjects who withdraw from treatment because of study-drug effects
Number of subjects who decrease their dose because of treatment-related effects
Correlation of plasma levels of EQU-001 with % seizure reduction
Correlation of plasma levels of biomarkers with % seizure reduction
Beyond the preview
Go deeper on NCT05063877.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05063877.