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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 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.

Detailed Summary:
Sponsor: University of Colorado, Denver

Current Primary Outcome: genetic differences between patients with Dravet Syndrome (SCN1A gene mutation) who appear to respond to high concentration cannabidiol (CBD) oil therapy versus those who do not. [ Time Frame: 1 day ]

Patients completing three months of therapy with a seizure reduction of >50% will be designated a "Responder" and patients who discontinue therapy for any reason prior to 3 months or have a <=50% seizure reduction will be designated "Non-Responder". Between-groups genetic analysis will be performed


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Colorado, Denver

Dates:
Date Received: August 27, 2014
Date Started: August 2014
Date Completion:
Last Updated: December 5, 2016
Last Verified: December 2016