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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
Sponsor:
Information provided by (Responsible Party):
Shaun Hussain, MD, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment
Refractory Childhood Epilepsy Drug: cannabidiol (CBD)

  Show Detailed Description

Study Type : Expanded Access
Official Title: Cannabidiol for the Treatment of Pediatric Epilepsy (Expanded Access/Compassionate Use Protocol)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


Intervention Details:
  • Drug: cannabidiol (CBD)
    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.
    Other Name: Epidiolex

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Age criteria between the ages of 1 and 17 years.
  2. 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.
  3. 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.
  4. VNS must be on stable settings for a minimum of 3 months.
  5. If on ketogenic diet, must be on stable ratio for a minimum of 3 months
  6. Written informed consent obtained from the patient or the patient's legal representative must be obtained prior to beginning treatment.

Exclusion Criteria:

  1. Use of any "community acquired" cannabidiol product over the last 3 months.
  2. Use of any investigational treatments over the last 3 months.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556008


Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles

Responsible Party: Shaun Hussain, MD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02556008     History of Changes
Other Study ID Numbers: SH001
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Shaun Hussain, MD, University of California, Los Angeles:
Children
Epilepsy
Cannabidiol

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases