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

NCT02783092 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-11-29

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Cannabidiol

Oral solution of cannabidiol 200 mg / mL dissolved in corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day)

DRUG

Placebo

The placebo will be an oral solution of corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day)

Sponsors & Collaborators

  • Antonio Waldo Zuardi

    lead OTHER

  • Prati Donaduzzi & Cia Ltda

    collaborator INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2024-07-10
Completion
2024-09-25

Countries

  • Brazil

Study Locations

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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 NCT02783092 on ClinicalTrials.gov