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

• Status: Active, not recruiting
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Many families of children with medically refractory epilepsy are choosing to use medicinal cannabinoids (MCBD) as an adjunctive alternative treatment option. The safety, tolerability and efficacy of these products are not known. The primary objective of this study is to determine how the use of MCBD affects children with medically refractory epilepsy in an observational study. Measures of evaluation to be used will include: laboratory values, developmental measures, seizure diaries and serial electroencephalographic (EEG) recordings.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Colorado Department of Public Health and Environment

Criteria

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).