Genetic Analysis Between Charlotte's Web Responders Versus Non- Responders in a Dravet Population



Status:Completed
Healthy:No
Age Range:Any - 50
Updated:12/17/2017
Start Date:August 2014
End Date:July 2017

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There is tremendous curiosity about medical marijuana and the treatment of epilepsy. In a
specific genetic epilepsy known as Dravet Syndrome, a mutation occurs affecting the SCN1A
gene. A specific strain of marijuana known as Charlotte's Web, available in Colorado, may
have activity in this catastrophic epilepsy syndrome. Anecdotal reports suggest both success
and lack of response with this therapy. Genetic analysis of the differences between Dravet
responders and non-responders may prove useful for identifying patients likely to be helped
by this therapy, as well as shed light on the putative mechanisms by which marijuana may
exert any antiepileptic effect.


Inclusion Criteria:

- age 1-50 with gene confirmed Dravet Syndrome

- uncontrolled epilepsy, having failed at least 2 prior treatments (including
appropriate Anti-epileptic drugs, ketogenic diet, vagus nerve stimulation Therapy)

- Seizure frequency should be more than 2 visually countable motor seizures per week
(tonic clonic, tonic, clonic, myoclonic, or astatic)

- care providers able to identify convulsive seizures, drop attacks, or tonic seizures,
or any combination of countable seizure types

- self- seeking therapy with Charlotte's Web strain of medical marijuana with the
assistance of a medical marijuana doctor, but are still naïve to therapy

- care provider able to complete seizure count diary

- able to obtain oral swab sample from subject with Dravet Syndrome

- agree to forfeit any right to results of genetic analysis

Exclusion Criteria:

- subjects having non-epileptic seizures that are not distinguishable from epileptic
seizures by the care provider

- prisoners

- pregnant women

- failure to forfeit right to results of genetic analysis
We found this trial at
1
site
777 Bannock St
Denver, Colorado 80204
(303) 436-6000
Principal Investigator: Edward Maa, MD
Phone: 303-602-5099
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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Denver, CO
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