Topiramate Add on Treatment in Refractory Epilepsy Patients: A Randomized Concentration-Controlled Clinical Trial
Abstract number :
2.238
Submission category :
Year :
2001
Submission ID :
3080
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
J. Christensen, MD, Centre for Clinical Pharmacology, University of Aarhus, Aarhus, Denmark; J.H. Poulsen, MD, Department of Biochemistry, Aarhus University Hospital, Aarhus, Denmark; F. Andreasen, MD, Centre for Clinical Pharmacology, University of Aarhu
RATIONALE: Topiramate is a relatively new antiepileptic drug that has been extensively studied in Europe and the United States. The drug seems to be as effective as more established antiepileptic drugs, but the potential value of plasma concentration measurements does not appear to have been carefully explored. Hence there is no established therapeutic drug level ([dsquote]therapeutic window[dsquote]).
This study explores the value of topiramate therapeutic drug monitoring.
METHODS: The study was a prospective, double-blind, randomized, parallel group, concentration-controlled trial with external adjustment of serum levels (triple-blind). Adult epilepsy patients with focal epilepsy and more than eight simple, complex or generalized seizures during an eight weeks baseline period were included. Patients were randomized to one of three topiramate plasma levels: low (2.0 mg/l), medium (10.5 mg/l) or high (19.0 mg/l). Topiramate was added to the current treatment during an eight weeks titration period followed by a 12 weeks observation period. The primary efficacy parameter was median reduction in seizure frequency during the observation period compared to the baseline period.
RESULTS: Sixty-five patients (39 women and 26 men) were block-randomized into the three approximately equal-sized groups. Study inclusion has been terminated and the last patients are expected to leave the study ultimo May 2001. Thereafter blinding will be broken and further results presented at the meeting.
CONCLUSIONS: Therapeutic drug monitoring of Topiramate may prove beneficial in the treatment of epilepsy patients.
Support: Janssen-Cilag A/S Denmark, Hede Nielsen Foundation, Svend and Ina Hansen Foundation, E. Danielsen and Wife Foundation, Danish Epilepsy Society and Danish Epilepsy Association.
Disclosure: Materials - Janssen-Cilag A/S, Denmark.