Participants who will assigned to receive add on MGCND00EP1 will receive carrier oil containing THC and CBD in ratio 20:1, (10% of cannabidiol and 0.5 % and (-)-trans-Δ9-tetrahydrocannabinol) .
Titration Dose: 1 to 2 mg/kg body weight/day. dose will be increased every week by 2 mg/kg body weight/day up to a maximum 25 mg/kg body weigh/day or maximum daily dose 800 mg (the smaller of those 2 values) (divided into two daily doses).
After titration, patients will be receiving a stable maintenance dose of IMP (up to 25 mg/kg BW per day or maximum daily dose 800 mg (whichever smaller)) for 6 weeks period.
During forth treatment period participants will commence a 2 weeks down-titration taper period, followed by 4 weeks observational follow up period of previous standard AE treatment without IMP.

Participants who are assigned to receive add on PLACEBO will be administered the carrier oil (without the active ingredients).
Titration Dose: 1 to 2 mg/kg body weight/day. dose will be increased every week by 2 mg/kg body weight/day up to a maximum 25 mg/kg body weigh/day or maximum daily dose 800 mg (the smaller of those 2 values) (divided into two daily doses).
After titration, patients will be receiving a stable maintenance dose of IMP (up to 25 mg/kg BW per day or maximum daily dose 800 mg (whichever smaller)) for 6 weeks period.
During forth treatment period participants will commence a 2 weeks down-titration taper period, followed by 4 weeks observational follow up period of previous standard AE treatment without IMP.

Resistant Epilepsy, Drug

Adolescent Epilepsy

Children Epilepsy

Children and Adolescents With Resistant Epilepsies

Patients will take cannabis oil during the study

MGCND00EP1

Patient will take carrier oil during the study

Placebo

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.

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.

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

Blood and urine collection

Schneider Children's Medical Center of Israel

University Children's Hospital Ljubljana University Medical Centre Ljubljana

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

Randomized, Double Blind, Placebo Controlled, Parallel Design Phase II b Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies

study drug overall efficiency as a seizure reducing treatment compared to placebo group

study drug overall efficiency as a seizure reducing treatment

Improvement in vital signs, lab test results and physical examination

MGC Pharmaceuticals d.o.o

Treatment with current antiepileptic therapy 28 days - Various combinations of anti-epileptic (AE) medications
Add on treatment 42 days (6 weeks) - titration period - MGCND00EP1 or placebo in addition to AE medications.
Add on treatment 42 days (6 weeks) Maintenance stable treatment period - MGCND00EP1 or placebo in addition to AE medications
Add on treatment 14 days (2 weeks)- taper - down titration period - MGCND00EP1 or placebo in addition to AE medications
Follow up 28 days - Standard/ previous AE treatment

Post Traumatic Stress Disorder

A fixed dose of 300-mg of a hemp-derived formulation of purified 99.9% cannabidiol oil will be taken once daily for 8 weeks for participants randomized to the CBD arm.

Cannabidiol (CBD) oil

Placebo solution will be taken once daily for 8 weeks by participants randomized to the placebo arm.

Placebo oil

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Use of CBD Oil in the Treatment of Posttraumatic Stress Disorder

Use of Cannabidiol (CBD) Oil in the Treatment of PTSD: A Placebo-Controlled Randomized Clinical Trial

Change from baseline in clinician-rated PTSD severity.

Change from baseline in clinician-rated global impressions.

Change from baseline in patient-rated symptoms of PTSD.

Change from baseline in patient-rated symptoms of depression.

Change from baseline in overall disability.

Michael J. Telch

Professor of Psychology

University of Texas at Austin

Each nightly dose of CBD/Placebo oil will be tagged with a code # on the plastic syringe containing the CBD oil or placebo oil. Both oils will have identical color and mint flavor. Two independent staff not connected to the study will be unblinded to the participants' assignment to condition.

Capsules containing cannabis extract, dissolved in high-oleic sunflower oil, and CBD/THC in a 16:1 ratio.

Capsules containing a high-oleic sunflower oil, calorie-equated to the active treatment. There will be no active compounds in the placebo treatment.
Following treatment with placebo, all participants in this group will begin treatment with medical cannabis.

Drug Resistant Epilepsy

The experimental intervention will begin with two weeks of titration (100 mg to 200 mg of CBD per day), followed by four weeks of treatment (maximum 300 mg of CBD per day) and four weeks of maintenance (maximum 300 mg of CBD per day). A two week washout phase will slowly decrease the daily dose (200 mg to 100 mg of CBD per day). All daily doses are equally divided into a morning and evening dose.

Medical Cannabis

The placebo intervention will begin with two weeks of titration, followed by four weeks of treatment. Participants will then be unblinded to their study group and begin two weeks of titration, four weeks of treatment, and two weeks of washout with medical cannabis, following the same dosing and schedule as the experimental group. All daily doses are equally divided into a morning and evening dose.

University Hospital Campus, London Health Sciences Centre

University Health Network - Toronto Western Hospital

Cannabis Extract in Refractory Epilepsy Study

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Cannabidiol Plus Tetrahydrocannabinol (CBD+THC) Given as Adjunctive Therapy in Patients With Refractory Seizures

QOLIE-31 is a 31-item measure assessing health-related quality of life in adults with epilepsy. Seven scales assess seizure worry, overall quality of life, emotional well-being, cognitive and medication effects, and social function.

WHOQOL-BREF is a 26-item measure of physical health, psychological health, social relationships, and environment.

QOLCE is a 55-item scale assessing health-related quality of life in children with epilepsy from the perspective of the parent or caregiver. It covers cognitive, emotional, social, and physical functioning.

NDDI-E is a 6-item questionnaire designed to screen for depression in adults with epilepsy.

QIDS is a 16-item measure designed to assess the severity of depressive symptoms.

GAD-7 is a 7-item questionnaire assessing severity of generalized anxiety disorder.

GASE is a single-item, 7-point global rating scale that was designed to assess the overall severity of epilepsy.

PSQI is a 19-item measure assessing subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication and daytime dysfunction.

PGIC is a 7-point scale assessing the patient's perspective of overall improvement and efficacy of treatment. Scores range from "very much improved" to "very much worse".

CGIC is a 7-point scale assessing the caregiver's perspective of overall improvement and efficacy of treatment. Scores range from "very much improved" to "very much worse".

BSI-53 is a 53-item measure assessing psychological profiles. It covers 9 primary domains: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism.

SDS is a 5-item measure assessing functional impairment in three inter-related domains: work/school, social, and family life.

The Epilepsy Research Program of the Ontario Brain Institute

Ontario Brain Institute

University of Toronto

University Health Network, Toronto

London Health Sciences Centre

MedReleaf

Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.

Diet Modification

Subjects will be administered in a double-blinded, randomized and cross-over design

Cannabidiol supplement

University of British Columbia

Cannabinoid Supplementation on Vascular and Cognitive Function

The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.

Body mass in kilograms divided by height in meters squared

Assesses inclusion/exclusion criteria and prior history of medical conditions.

Measured using a 10 cm visual analogue scale

Computerized battery of neuropsychological tests

Step-wise exercise test on cycle ergometer

Individual values will be reported in figures if applicable.

Phil Ainslie

Professor

Lexaria Bioscoence Corp

Epileptic Encephalopathy

A cannabidiol (CBD): tetrahydrocannabinol (Δ9 THC) 20:1 ratio product will be provided as an oil-based suspension.

CanniMed® 1:20

Dosage Related Efficacy and Tolerability of Cannabidiol in Children With Treatment-Resistant Epileptic Encephalopathy: Preliminary Results of the CARE-E Study

University of Manitoba

Universite de Montreal

University of Saskatchewan

Cannabidiol in Children With Refractory Epileptic Encephalopathy

Cannabidiol in Children With Refractory Epileptic Encephalopathy: A Phase 1 Open Label Dose Escalation Study (CARE-E)

For participants taking clobazam who become excessively sedated

For participants taking clonazepam who become excessively sedated

Measure interactions with any anti-convulsants participants may be already on

Side effect rating scale, includes items related to sleepiness/lethargy, irritability, nausea/vomiting and diarrhea

tetrahydrocannabinol/seizures

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

Use of CBD Oil in the Treatment of Posttraumatic Stress Disorder

Cannabis Extract in Refractory Epilepsy Study

Cannabinoid Supplementation on Vascular and Cognitive Function

Cannabidiol in Children With Refractory Epileptic Encephalopathy

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