Overview

A Double-Blind Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epilepsy

Status:
Recruiting

Trial end date:
2021-12-30

Target enrollment:

Participant gender:

Summary

The purpose of this study is to assess the efficacy of the adjuvant use of cannabidiol administered twice daily in doses of 5-25 mg/kg/day through the proportion of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only). Primary end point(s): Rate of responsive patients; that is, participants with at least 50% decrease in the frequency of epileptic seizures in the last month of the trial relative to baseline (pretreatment with AEDs only).

Phase:

Phase 3

Details

Lead Sponsor:

Antonio Waldo Zuardi

Collaborator:

Prati Donaduzzi & Cia Ltda

Treatments:

Cannabidiol