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Safety, Tolerability, and Exploratory Efficacy of Adjunctive EQU-001 for Seizures in Adults With Epilepsy

Phase 2

Waitlist Available

Research Sponsored by Equilibre Biopharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 84

Summary

This trial is testing a new drug for epilepsy to see if it is safe and effective.

Eligible Conditions

Epilepsy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in the Quality of Life in Epilepsy-31-P (QOLIE-31-P) scale score as compared with baseline in treatment cohort as compared with placebo.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Study drug EQU-001Experimental Treatment1 Intervention

10mg capsules or 20 mg EQU-001 capsules totally 10 mg, 20 mg, 40 mg, 60 mg will be administered once orally daily to active-treatment subjects for 12-weeks with the option for open-label extension. During the open-label extension, subjects taking 60 mg dose for 4 weeks or longer may increase to 80 mg per day dose, at the discretion of the PI. Intervention: Drug : EQU-001

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo control 10 mg capsule or 20 mg capsules totaling to 10 mg, 20 mg, 40mg or 60 mg will be administered once daily orally for 12 weeks with the option for open-label extension. Intervention: Drug: Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EQU-001

2021

Completed Phase 1

~90

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