Start Date
May 30, 2024
Primary Completion Date
May 30, 2024
Study Completion Date
May 30, 2024
MGCND00EP1
Patients will take cannabis oil during the study
Placebo
Patient will take carrier oil during the study
ECG
"A standard 12-lead ECG will be recorded using digital ECG recording equipment provided to the investigational site. The ECG has to be performed prior to laboratory samplings at time points indicated in the Schedule of Assessments.~The ECG recording will be reviewed by investigator and case of need consultation with cardiologist will be performed. The investigator has the final decision on the clinical significance of the ECG results."
EEG
An EEG is an electrophysiological monitoring method that records the electrical activity and measures voltage fluctuations resulting from ionic current within the neurons of the brain. In clinical contexts, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time.
Blood and urine collection
safety blood tests - hematology\\blood count and biochemistry standard blood tests urinalysis - urine test analysis
University Children's Hospital Ljubljana University Medical Centre Ljubljana, Ljubljana
Schneider Children's Medical Center of Israel, Petach Tikvah
Lead Sponsor
MGC Pharmaceuticals d.o.o
INDUSTRY