Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy — CBD  

Epilepsy Clinical Trial

Official title: Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy

Status Approved for marketing

Clinical Trial Summary

This is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol.

Clinical Trial Description

This study will test if Cannabidiol (CBD) therapy is safe in humans and reduces the number and/or severity of seizures in patients with drug resistant epilepsy when taken in addition to current anti-epileptic drugs (AEDs).

To be eligible, subjects must:

• have drug-resistant epilepsy

• be between 1 and 60 years of age

Subjects may participate for up to 2 years and may continue to receive the drug as available, until the compassionate use is terminated or the drug becomes approved by the FDA.

The study includes:

• Baseline, Screening and 2 phone calls

• 12 week drug titration (6 visits) and 5 phone calls

• Approximately 1 year and 9 month Treatment period (7 visits)

Subjects will come in for visits approximately every two weeks for the first three months and then quarterly for the remainder of the study. Subjects' antiepileptic drug levels will be tested to monitor for drug interactions. Lab assessments (complete blood count,CBC; comprehensive metabolic panel, CMP; urinalysis) will be performed to monitor for changes in bone marrow, liver, and kidney function to ensure safe use.

Cannabidiol will be in the form of 100 mg/ml oral solution. Subjects will be given CBD to take in addition to their current anti-epileptic drug (AED) regimen. ;

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

• NCT number: NCT02660255
• Study type: Expanded Access
• Source: University of Nebraska
• Status: Approved for marketing