Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy (CBD)
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|ClinicalTrials.gov Identifier: NCT02660255|
Expanded Access Status : Approved for marketing
First Posted : January 21, 2016
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment|
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 (CBC, 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.
|Study Type :||Expanded Access|
|Official Title:||Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy|
- Drug: Cannabidiol
Formulation: 100mg/ml CBD (Epidiolex) SolutionOther Name: Epidiolex
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660255
|Principal Investigator:||Deepak Madhavan, MD||University of Nebraska|