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| Name | Class |
|---|---|
| Colorado Department of Public Health and Environment | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with medically refractory epilepsy | Pediatric epilepsy patients who are followed at Children's Hospital Colorado with medically refractory epilepsy, and whom the family has decided to treat with medical cannabis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Cannabis | Drug | Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in background and architecture of seizures confirmed by non-investigational EEG | Prolonged EEG recordings lasting 24-48 hours (whichever is clinically indicated) will be performed in either the home setting as an ambulatory EEG or in the hospital in the Epilepsy Monitoring Unit. This decision will be made on a clinical basis. This will allow for objective quantification of seizures in children with frequent seizures that occur on a daily basis and background EEG changes for other children. Two EEGs will be done: one at baseline, and one at the end of the study. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
| Seizure Frequency | Each subject will maintain a seizure diary. Rescue drug use and VNS (Vagus Nerve Stimulation) activations will be tracked as an adjunct to all current anti-seizure medications. Frequency of status epilepticus will be tracked as well as hospital visits for seizures or adverse events from MCBD. Clinical evaluations will be taken every 2 months throughout the duration of the study. Subjects will be monitored every 2 weeks by telephone and/or email. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
| Pediatric Epilepsy Side Effects Questionnaire | Side effects will be evaluated using PESQ (Pediatric epilepsy Side Effects Questionnaire). This questionnaire will be administered 4 weeks, 8 weeks, and 12 weeks after baseline. | Baseline, 4 weeks, 8 weeks, and 12 weeks |
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Inclusion Criteria:
Male or Female >1 month of age
Documentation of a diagnosis of medically refractory epilepsy as evidenced by medical records, genetic testing and/or the following clinical features:
Baseline seizure frequency of at least 2 per week of the any of the following types:
1-3 baseline anti-seizure medications at stable doses for a minimum of 4 weeks prior to enrollment.
Written informed consent obtained from the patient or the patient's legal representative.
Exclusion Criteria:
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Pediatric epilepsy patients who are followed at Children's Hospital Colorado with medically refractory epilepsy, and whom the family has decided to treat with medicinal cannabis. Children who have not been treated with medically accepted standard treatment for their epilepsy condition will not be accepted into this study as the researchers do not want to be misperceived as condoning the use of medical marijuana in lieu of standard treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Knupp, MD | Assistant Professor of Pediatrics and Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2022 | |
| Reset | Mar 24, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2022 | Mar 24, 2022 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D064086 | Medical Marijuana |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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Whole blood samples will be collected
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |