The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy

This is an observational study of a family's choice to use MCBD and the effect of this
substance on medically refractory epilepsy in children. The risks associated with this use
are not well known. There have recently been reports of stroke, liver dysfunction and altered
anticonvulsant levels. In addition, there have been long term risks reported of decreased
memory function, cognitive problems and executive function abnormalities. This study does not
condone or advocate the use of the substance but merely seeks to document the short term
effects of the use in this population. It should be noted that providers at Children's
Hospital Colorado are not registered providers for medicinal cannabis; therefore, this will
be an observational study of effects of this substance as prescribed by other physicians
outside of our institution.

Inclusion Criteria:

1. Male or Female >1 month of age

2. Documentation of a diagnosis of medically refractory epilepsy as evidenced by medical
records, genetic testing and/or the following clinical features:

- Failure to control seizures despite an appropriate trial of two anticonvulsant
medications at therapeutic doses

3. Baseline seizure frequency of at least 2 per week of the any of the following types:

- Generalized tonic-clonic

- Clonic

- Tonic

- Hemiconvulsive

- Drop attacks

- Focal motor

- Epileptic spasms

4. 1-3 baseline anti-seizure medications at stable doses for a minimum of 4 weeks prior
to enrollment.

5. Written informed consent obtained from the patient or the patient's legal
representative.

Exclusion Criteria:

1. Epilepsies associated with rapidly progressing neurodegenerative diseases ex:
Rasmussen encephalitis, and tumors.

2. Epilepsies associated with treatable inborn errors of metabolism

3. Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the patient or the quality of the data.

4. Non-epileptic events.

5. Current use of MCBD products (Note: Patient is eligible if currently using MCBD but
will be switching to a different product).