Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT02229032
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
50 Years
Study:
NCT02229032
Study Brief:
Protocol Section:
NCT02229032