Cannabidiol for Pediatric Epilepsy (Compassionate Use)
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ClinicalTrials.gov Identifier: NCT02556008
Expanded Access Status :
No longer available
First Posted : September 22, 2015
Last Update Posted : May 3, 2017
University of California, Los Angeles
Information provided by (Responsible Party):
Shaun Hussain, MD, University of California, Los Angeles
This is an open-label observational study of pure CBD for the treatment for 25 children with intractable epilepsy. As pure CBD is not FDA approved, the investigators are conducting this study via the FDA expanded access mechanism on a compassionate use basis. The target patient population is children with severe refractory epilepsy who have exhausted all other reasonable avenues of treatment. These are patients for whom the risks of a relatively untested product are outweighed by the potential benefit. Using seizure-diaries maintained on a routine clinical basis, seizure frequency will be assessed four weeks prior to initiation of CBD, one month after CBD initiation, and at least every 3 months thereafter. CBD will be administered as an adjunct to all current anti-epileptic therapies.
Treatment will begin with 2 mg/kg/day given in two divided doses. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given.
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Layout table for eligibility information
Ages Eligible for Study:
1 Year to 17 Years (Child)
Sexes Eligible for Study:
Age criteria between the ages of 1 and 17 years.
Documentation of a diagnosis of drug resistant epilepsy as evidenced by failure to control seizures despite appropriate trial of two or more AEDs at therapeutic doses. Documentation must include the diagnosis of epilepsy type or epilepsy syndrome, as well as the underlying cause, when known.
Between 1-3 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment. Vagus nerve stimulator (VNS), ketogenic diet and modified Atkins diet do not count toward this limit.
VNS must be on stable settings for a minimum of 3 months.
If on ketogenic diet, must be on stable ratio for a minimum of 3 months
Written informed consent obtained from the patient or the patient's legal representative must be obtained prior to beginning treatment.
Use of any "community acquired" cannabidiol product over the last 3 months.
Use of any investigational treatments over the last 3 months.
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete entire study.