drugset / Trial / NCT02700412
University of Alabama at Birmingham (UAB) Adult CBD Program
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating debilitating, drug-resistant epilepsy.
Timeline
- Start
- 2015-04
- Primary completion
- 2019-08-08
- Completion
- 2019-08-08
Publications
- Background Duncan JS, Sander JW. The Chalfont Seizure Severity Scale. J Neurol Neurosurg Psychiatry. 1991 Oct;54(10):873-6. doi: 10.1136/jnnp.54.10.873.
- Background Pinheiro, J.C. and Bates, D.M. (2000). Mixed-Effects Models in S and S-Plus. Springer, Verlag, New York.
- Szaflarski JP, Hernando K, Bebin EM, Gaston TE, Grayson LE, Ampah SB, Moreadith R. Higher cannabidiol plasma levels are associated with better seizure response following treatment with a pharmaceutical grade cannabidiol. Epilepsy Behav. 2019 Jun;95:131-136. doi: 10.1016/j.yebeh.2019.03.042. Epub 2019 Apr 29.
- Warren PP, Bebin EM, Nabors LB, Szaflarski JP. The use of cannabidiol for seizure management in patients with brain tumor-related epilepsy. Neurocase. 2017 Oct-Dec;23(5-6):287-291. doi: 10.1080/13554794.2017.1391294. Epub 2017 Oct 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 25 mg/kg | Oral |
| Subject | Cannabidiol | Other / unclassified | 50 mg/kg | Oral |