Quality of Life
Conditions
Interventions
This is a double-blind study with a defined sample of 30 participants who will be divided into two groups, randomized 1:1 (15 patients per group of both genders). Randomization will be done in blocks
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Sponsors
Instituto de Medicina Integral Professor Fernando Figueira
Instituto de Medicina Integral Professor Fernando Figueira
Eligibility
Age
2 Years to 5 Years
Inclusion criteria
Inclusion criteria: Children aged 2 to 5 years; of both genders; diagnosis of Epilepsy of structural or metabolic etiology; diagnosed with drug-resistant Epilepsy according to the International League Against Epilepsy criteria; presenting at least four epileptic seizures during one month; being on treatment with at least two concomitant antiseizure medications at stable doses for at least one month
Exclusion criteria
Exclusion criteria: Use of corticosteroids in the six months prior to the study; prior treatment with cannabidiol in the three months prior; liver dysfunction defined by at least one of the following criteria: alanine aminotransferase or aspartate aminotransferase greater than 5 times the upper limit of normal and/or total bilirubin greater than 2 times the upper limit of normal; international normalized ratio greater than 1.5, not correctable with vitamin K administration; inadequate supervision by parents and/or guardians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the average daily frequency of epileptic seizures is expected after 4 weeks of treatment, compared to baseline. This outcome will be verified using the daily seizure record method by the patient/caregiver, collected via weekly telehealth consultations. To verify if the outcome actually occurred, we will observe the percentage reduction in the average number of seizures compared to the baseline period. | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in the average daily frequency of epileptic seizures is expected after 8 and 12 weeks of treatment, compared to baseline. This outcome will be verified using the daily seizure record method, collected via weekly telehealth. To verify if the outcome actually occurred, we will observe the absolute and percentage reduction in the number of seizures during these periods.;Evaluate the treatment response rate at the end of 12 weeks. This outcome will be verified using the seizure record method collected via weekly telehealth. To verify if the outcome actually occurred, we will observe the percentages and proportions of participants who achieved a reduction equal to or greater than 25%, 50%, 75%, and 100% in seizure frequency.;To evaluate the variation in the frequency of epileptiform discharges after 12 weeks of treatment. This outcome will be verified using the Electroencephalogram (EEG) method. To verify if the outcome actually occurred, we will observe the percentage variation in the number of epileptiform discharges between the intervention and control groups.;To assess the improvement in the quality of life of children at 4, 8, and 12 weeks of treatment, compared to baseline. This outcome will be verified using the Childhood Epilepsy Health-Related Quality of Life Questionnaire method. To verify if the outcome actually occurred, we will observe the variation in the raw and weighted scores of the questionnaire.;A reduction in caregiver burden and stress levels is expected at 4, 8, and 12 weeks, compared to baseline. This outcome will be verified using the Zarit Burden Interview Scale method. To verify if the outcome actually occurred, we will observe the decreasing variation in the total scores of the scale.;To assess the safety and tolerability of cannabidiol use throughout the treatment period. This outcome will be verified through clinical monitoring and active case finding conducted via telehealth (in weeks 4, 8, and 12). To verify if the outcome actua | — |
Countries
BR
Contacts
Public ContactLucas Alves
Instituto de Medicina Integral Prof. Fernando Figueira
Outcome results
None listed