Genetic Analysis Between Charlotte's Web Responders Versus Non- Responders in a Dravet Population
Completed
Conditions studied: Dravet Syndrome
In brief
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.
Key facts
- Study ID
- NCT02229032
- Run by
- University of Colorado, Denver
- People needed
- 19
- Starts
- 2014-08-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2017-12-15
Who can join
Age: any, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Denver Health Medical Center — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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