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EQU-001 for 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 14, 42, 70, 98
Awards & highlights

Study Summary

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

Eligible Conditions
  • Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14, 42, 70, 98
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14, 42, 70, 98 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, November 2017, treatment-related adverse events (TRAEs) in each dose cohort as compared with placebo.
Secondary outcome measures
Change in C-SSRS responses as compared with baseline in treatment cohort as compared with placebo.
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.
Correlation of plasma levels of EQU-001 with % seizure reduction
+7 more

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

Find a Location

Who is running the clinical trial?

Equilibre BiopharmaceuticalsLead Sponsor
1 Previous Clinical Trials
81 Total Patients Enrolled
Equilibre Biopharmaceuticals B.V.Lead Sponsor
2 Previous Clinical Trials
108 Total Patients Enrolled
Ya-El Mandel-Portnoy, PhDStudy DirectorEquilibre

Media Library

EQU-001 Clinical Trial Eligibility Overview. Trial Name: NCT05063877 — Phase 2
Epilepsy Research Study Groups: Study drug EQU-001, Placebo
Epilepsy Clinical Trial 2023: EQU-001 Highlights & Side Effects. Trial Name: NCT05063877 — Phase 2
EQU-001 2023 Treatment Timeline for Medical Study. Trial Name: NCT05063877 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Exploratory Efficacy of Adjunctive EQU-001 for Seizures in Adults With Epilepsy
2021. "Safety, Tolerability, and Exploratory Efficacy of Adjunctive EQU-001 for Seizures in Adults With Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05063877.
All > Lgs Foundation
~12 spots leftby May 2025
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