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

NCT05063877 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-05-15

No results posted yet for this study

Summary

This is a double-blind, placebo controlled, randomized study of dose-ranging safety, tolerability, exploratory efficacy of adjunctive EQU-001 for seizures using the continuous reassessment method in patients diagnosed with epilepsy.

Conditions

Interventions

DRUG

Placebo

Matched placebo

DRUG

EQU-001

EQU-001 in 10 mg and 20 mg capsules

Sponsors & Collaborators

  • Equilibre Biopharmaceuticals B.V.

    lead INDUSTRY

Principal Investigators

  • Ya-El Mandel-Portnoy, PhD · Equilibre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2022-10-11
Completion
2023-10-11
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063877 on ClinicalTrials.gov