Jim Fisher, PharmD receives clinical trial agreement with Lundbeck Inc.
"Open-Label Study to Assess the Safety and Tolerability of Intravenous Carbamazepine as Short-Term Replacement of Oral Carbamazepine in Adult Patients with Epilepsy"
Carbamazepine has been a first-line agent for the treatment of partial and generalized tonic-clonic seizures for over 35 years, with a favorable safety profile in children and adults. A drawback is that carbamazepine is only available for oral administration. This places patients receiving carbamazepine for epilepsy at a disadvantage if they are unable to tolerate oral medications due to illness, surgery, or a change in mental status. In these situations, the alternatives are to miss one or more doses or switch to another antiepileptic medication.
The development of a carbamazepine preparation for IV administration has been hindered due to the inability to maintain carbamazepine in a solution. Lundbeck Inc. is currently conducting a study to test the safety and tolerability of an intravenous form of carbamazepine in individuals with epilepsy who are presently taking an oral form (tablets, capules or liquid) of carbamazepine. This formulation utilizes a ß-cyclodextrin derivative, Captisol™, as a solubilizing agent. The availability of an intravenous alternative to oral carbamazepine will allow for the consistent use of carbamazepine during times when taking medication orally is not possible. For example, people may experience a loss of consciousness due to a seizure or vomiting due to the flu. They may be having surgery or be experiencing other illness that does not allow them to take their medications by mouth. Presently patients with these problems are changed to one of the antiepileptic medications that is already available for intravenous administration. The concern with this approach is that their seizures may not be as well-controlled with this substitution.
James Fischer, PharmD, Department of Pharmacy Practice, is the principal investigator conducting a study of this drug at UIC in collaboration with Yevgenya Kaydanova, MD, Department of Neurology and Mitra Habibi, PharmD and Patricia Fischer, RN, Department of Pharmacy Practice. This study is testing the safety and tolerability of intravenous carbamazepine administered as multiple 15 infusions and a single 5 minute infusion in adult patients with epilepsy. 30 centers across the United States are enrolling 105 subjects in this research. Robert Anders, Pharm D, UIC class of 1985, Vice President of US Process and Systems at Lundbeck, Inc. has been instrumental in overseeing this research.