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The Research Pharmacy at each site will receive the study product from Canni Med® for subsequent distribution to their site’s participants.
As an oil-based suspension the product will be taken orally or by gastrostomy tube and the volume varies according to the weight of the participant.
Recruitment Phase: Prospective participants will be directly identified and recruited through the caregivers by study physicians at each study site.
The study will recruit participants between the ages of 1–10 years with an epileptic encephalopathy resistant to standard medical treatment.
The study will aim to enroll 28 children from four Canadian cities (anticipated seven participants per site).
A single lot number of product was provided by Canni Med® for this study to ensure consistency of dosing.
The product was purchased from Canni Med® at cost and this research remained independent of the company by securing all funding through external research grants.