Status:
COMPLETED
Genetic Analysis Between Charlotte's Web Responders Versus Non- Responders in a Dravet Population
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Denver Health Medical Center
Conditions:
Dravet Syndrome
Eligibility:
All Genders
Up to 50 years
Brief Summary
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 str...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02229032
Start Date
August 1 2014
End Date
July 1 2017
Last Update
December 15 2017
Active Locations (1)
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1
Denver Health Medical Center
Denver, Colorado, United States, 80204