Cannabidiol for Drug Resistant Pediatric Epilepsy (Expanded Access Use)


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ClinicalTrials.gov Identifier: NCT03676049

Expanded Access Status :
Available

First Posted : September 18, 2018

Last Update Posted : September 18, 2018

Sponsor:

Information provided by (Responsible Party):

John, University of Mississippi Medical Center

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Brief Summary:

This is a treatment study under an approved Expanded Use IND protocol for using Cannabidiol (CBD) Extract. CBD will be used for the treatment of 5-10 children with drug resistant epilepsy. The CBD used in this study is prepared at the University of Mississippi under approval of the National Institute on Drug Abuse (NIDA) for its preparation and FDA approval under an expanded access mechanism on a compassionate use basis. The target patient population is who would otherwise have no appropriate remaining treatment modality left. These are patients for whom the risks of a relatively untested product are outweighed by the potential benefit. Using seizure-diaries to register seizure frequency, drug log and questionnaire to measure parent/patient quality of life and side effects will be assessed in each visit. Visits are: baseline, 4, 8, and 12 weeks visit. A 24 weeks visit (6 months) will be performed if the patient is stable on therapy during the 3 initial months and want to continue on the study for 3 more months. CBD will be administered as an adjunct to all current anti-epileptic therapies.




Drug Resistant Epilepsy


Drug: Cannabidiol

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Study Type :

Expanded Access




Expanded Access Type :

Intermediate-size Population

Official Title:
Cannabidiol (CBD) Cannabis Extract Oral Solution for Drug Resistant Pediatric Epilepsy (Expanded Access Use)

Resource links provided by the National Library of Medicine

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Intervention Details:
Drug: Cannabidiol

CBD will be administered as an adjunct to all current antiepileptic drugs. A dosing titration period will start with 100 mg/day, with 50mg BID dosing, and will be titrated monthly as tolerated based on clinical response, up to 300mg/day. This is based on a targeted dosing of 2.5 —5—7.5 mg/kg/d.

Other Name: CBD

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Information from the National Library of Medicine


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Ages Eligible for Study:
5 Years to 19 Years (Child, Adult)
Sexes Eligible for Study:
All

Inclusion Criteria:

Patients meeting the following criteria will be considered eligible for this study:

Age 5-19 years old
Documentation of a diagnosis of drug resistance epilepsy as evidenced by failure to control seizures despite appropriate trial of three or more anti-epileptic drugs at therapeutic doses. Some of these drugs include Brivaracetam, Carbamazepine, Clobazam, Clonazepam, Diazepam, Divalproex Sodium, Eslicarbazepine Acetate, Ethosuximide, Felbamate, Gabapentin, Lacosamide, Lamotrigine, Levetiracetam, Lorazepam, Oxcarbazepine, Perampanel, Phenobarbital, Phenytoin, Pregabalin, Rufinamide, Valproic Acid, Vigabatrin, Zonisamide. Documentation must include the diagnosis of epilepsy type or epilepsy syndrome (if possible), as well as the underlying case, when known.
Between 1-3 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment. Vagus nerve stimulator, and dietary therapies do not count toward this parameter, but are not bases for exclusion.
Vagus nerve stimulator must be on stable settings for a minimum of 3 months.
A history of significant epilepsy severity and neurocognitive delays, specifically a baseline history of being nonverbal and non-ambulatory without assistance

Exclusion Criteria:

The patient may not enter the study if ANY of the following apply:

Patients with resectable epilepsy or syndromes where dietary or other therapy is first line will not be enrolled prior to attempting those therapies with failure OR parental refusal of said therapies.
Treatment with any artisanal preparation containing or possible containing CBD during the month before initiation of the study drug.
Allergy to CBD or any cannabinoid.
Unable to comply with study visits/requirements.
CBD is contraindicated in pregnancy and during breast-feeding. Female subjects who are pregnant or breastfeeding will be excluded from treatment with CBD. Patients of childbearing potential will be screened for pregnancy prior to enrollment and during the study if a potential for pregnancy arise. A blood pregnancy test will be used. Additionally, for patients of childbearing potential, enrollment criteria will require the use of highly effective contraception (e.g. double barrier, abstinence, or IUD) for the duration of treatment with CBD. Therefore, parent/guardian of female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if the child become pregnant during the study.

Significant impaired hepatic function at screening as characterized by one of the following:

i. Alanine aminotransferase [ALT] >5 upper limit of normal (ULN) and total bilirubin (TBL) >2 ULN ii. ALT or Aspartate aminotransferase (AST) >3 ULN and either TBL >2 ULN or international normalized ratio (INR) >1.5



History or presence of alcohol or substance abuse
Use of other cannabis or CBD products

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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): NCT03676049



University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

John

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Responsible Party:
John, M.D., Associate Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:

NCT03676049
History of Changes

Other Study ID Numbers:

2017-0259
First Posted:
September 18, 2018

Key Record Dates

Last Update Posted:
September 18, 2018

Last Verified:
September 2018

Keywords provided by John, University of Mississippi Medical Center:




Children, Epilepsy, Cannabidiol

Additional relevant MeSH terms:




Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases


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