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| ID | Type | Description | Link |
|---|---|---|---|
| FLGV | Other Grant/Funding Number | Florida Department of Health |
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| Name | Class |
|---|---|
| James and Esther King Biomedical Research Program | OTHER |
The main goal of this study is to provide treatment with cannabidiol (CBD) to children with drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol. As the controlled therapeutic use of CBD in children is novel, the primary objective of this study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy in children that have exhausted the majority of FDA approved antiepileptic drug treatment options.
Fifty, (50) children will be provided CBD as part of the Principal Investigator's Physician Expanded Access IND. CBD will be administered as an adjunct to all current antiepileptic drugs. After the screening visit, a 4 week baseline period will be followed and seizures will be recorded in the seizure diary given to the patient at this time. The patients will be clinically evaluated at baseline, once a month for three months and once every three months thereafter. For the first week after study initiation, patients will be called at day 3 to review any changes in condition and again at day 7 to review any changes in condition and to determine whether an increase in dosing is required. Subsequently, patients will be called each week during the titration period to review any changes in condition and determine whether an increase in dosing is required. Maximal dose titration should be achieved in most patients within 5 weeks. In order to ensure safe use at higher doses, patients who receive more than 600 mg of daily CBD will be evaluated at least monthly until they achieve steady state at their final fixed maintenance dose. The investigator will be available by telephone or email throughout the initial four months of the study in between the visits.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cannabidiol | Drug | All subjects will have a dosing titration starting with 25 mg/kg/day and will be titrated weekly as tolerated based on clinical response. All subjects will be clinically evaluated at baseline, once a month for three months and every three months thereafter. In order to ensure safe use at higher doses, patients receiving more than 600 mg of daily CBD will be evaluated at least monthly until they achieve steady state at the final fixed maintenance dose. |
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| Blood Test | Other | All subjects will have the following clinical laboratory tests including changes in bone marrow (CBC), liver (AST, ALT), and kidney function (creatinine, electrolytes, BUN) will be assessed at baseline, each month during months 1 to 3, and every 3 months thereafter. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Winesett, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Flordia CRC | Gainesville | Florida | 32610 | United States | ||
| Nicklaus Children's Hospital, Miami Children's Health System |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Miami |
| Florida |
| 33155 |
| United States |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |