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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Geisinger Clinic | OTHER |
The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug |
|
Inclusion Criteria:
Ages between 1 year old and 20 years old, male or female at the first visit, Week -4 (at time informed consent form is signed)
Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented with medical records and/or the following clinical features (must have all 3 of the following):
Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit.
VNS must be on stable settings for a minimum of 3 months.
If on the ketogenic diet, must be on stable ratio for a minimum of 3 months.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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