Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 30, 2024

Primary Completion Date

May 30, 2024

Study Completion Date

May 30, 2024

Conditions
Resistant Epilepsy, DrugAdolescent EpilepsyChildren EpilepsyChildren and Adolescents With Resistant Epilepsies
Interventions
DRUG

MGCND00EP1

Patients will take cannabis oil during the study

DRUG

Placebo

Patient will take carrier oil during the study

DIAGNOSTIC_TEST

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."

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Blood and urine collection

safety blood tests - hematology\\blood count and biochemistry standard blood tests urinalysis - urine test analysis

Trial Locations (2)

1000

University Children's Hospital Ljubljana University Medical Centre Ljubljana, Ljubljana

4920235

Schneider Children's Medical Center of Israel, Petach Tikvah

Sponsors
All Listed Sponsors
lead

MGC Pharmaceuticals d.o.o

INDUSTRY