Trials / Approved For Marketing
Approved For MarketingNCT02660255
Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- University of Nebraska · Academic / Other
- Sex
- All
- Age
- 1 Year – 60 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cannabidiol | Formulation: 100mg/ml CBD (Epidiolex) Solution |
Timeline
- First posted
- 2016-01-21
- Last updated
- 2023-10-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02660255. Inclusion in this directory is not an endorsement.