A Double-blind, Randomized Placebo-controlled Trial to Evaluate Efficacy and Safety of Cannabidiol as an add-on Therapy for Treatment in Refractory Epileptic Crisis in Children and Adolescents

Antonio Waldo Zuardi1 site in 1 country126 target enrollmentJanuary 9, 2019

ConditionsEpilepsy

InterventionsCannabidiol Placebo

DrugsCannabidiol Placebo

Overview

Phase: Phase 3
Intervention: Cannabidiol
Conditions: Epilepsy
Sponsor: Antonio Waldo Zuardi
Enrollment: 126
Locations: 1
Primary Endpoint: Frequency of epileptic seizures
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

January 9, 2019

End Date

September 25, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Antonio Waldo Zuardi

Responsible Party

Sponsor Investigator

Principal Investigator

Antonio Waldo Zuardi

MD, PhD, Professor

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

•Men and women aged 2 years to 18 years.
•Diagnosis of treatment-resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE) (Kwan et al., 2010).
•Participants with at least 4 epileptic seizures with intervals no longer than 21 days.
•In treatment with up to 3 AEDs concomitantly and at stable doses for at least 1 month before the baseline assessment and expected to remain stable during the period of the trial. Vagus nerve stimulation (VNS) will be considered as an AED.
•Availability of a legal guardian able to follow the protocol (e.g., understand and fill up diaries) and visitation and medication schemes, according to the decision of the investigator.
•Availability of brain neuroimaging exams (magnetic resonance or computed tomography) collected within the last 5 years.
•No significant comorbid conditions, according to medical decision, to other criteria in this Protocol, and to additional assessments: medical records, blood pressure, heart rate, and temperature measures, physical exam, ECG, EEG, and laboratory tests.
•Women in reproductive age may be included as long as they are sexually abstinent or using effective contraceptive methods.
•Participants and their legal guardians, when applicable, must sign an informed consent form approved by the local ethics committee.

Exclusion Criteria

•Occurrence of simple partial seizures (preserved consciousness) only, with no motor symptomatology.
•History or presence of pseudoseizures.
•History of suicide attempt.
•History of major depression.
•Pregnancy.
•Drug use.
•Hypertension.
•Participants with severe dysphagia and no gastric or nasogastric tubes.
•Current treatment with drugs that may significantly affect the metabolism of CBD, except AEDs if stable for at least 1 month before the screening interview.
•Presence of any clinical or neuroimaging finding suggestive of brain disorders, brain tumors, or metabolic or neurodegenerative diseases of rapid progression.