Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT02461706
Brief Summary:
The main goal of this study is to provide treatment with cannabidiol (CBD) to children with drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol. As the controlled therapeutic use of CBD in children is novel, the primary objective of this study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy in children that have exhausted the majority of FDA approved antiepileptic drug treatment options.
Detailed Description:
Fifty, (50) children will be provided CBD as part of the Principal Investigator's Physician Expanded Access IND. CBD will be administered as an adjunct to all current antiepileptic drugs. After the screening visit, a 4 week baseline period will be followed and seizures will be recorded in the seizure diary given to the patient at this time. The patients will be clinically evaluated at baseline, once a month for three months and once every three months thereafter. For the first week after study initiation, patients will be called at day 3 to review any changes in condition and again at day 7 to review any changes in condition and to determine whether an increase in dosing is required. Subsequently, patients will be called each week during the titration period to review any changes in condition and determine whether an increase in dosing is required. Maximal dose titration should be achieved in most patients within 5 weeks. In order to ensure safe use at higher doses, patients who receive more than 600 mg of daily CBD will be evaluated at least monthly until they achieve steady state at their final fixed maintenance dose. The investigator will be available by telephone or email throughout the initial four months of the study in between the visits.
Study:
NCT02461706
Study Brief:
Protocol Section:
NCT02461706