“Seizure frequency improves in patients with epilepsy participating in clinical drug studies even when they do not continue to receive the experimental drug,” said Nathan Fountain, M.D., Associate Professor of Neurology at the University of Virginia, School of Medicine and Director of the FE Dreifuss Comprehensive Epilepsy Program, today at the 58th annual AES conference in New Orleans.

“Overall there is a perception among patients with epilepsy that participation in clinical trials may be efficacious for only the few who receive the drug treatment versus the placebo, or even that participating in a drug study may lead to worsening of seizures. We think this is generally unfounded which led us to undertake this study,” said Fountain.

In the recent study conducted by Fountain and colleagues demographic and mean seizure frequency data from patients entering antiepileptic drug studies were collected from January 1999-February 2004. These patients were all receiving medical care at the FE Dreifuss Comprehensive Epilepsy Program and all of them had partial onset seizures. 42 subjects were reviewed from 8 studies; 22 starting in double-blind studies and 20 in pharmacokinetic or tolerability open-label studies. Seizure frequencies were obtained from seizure calendars, which were completed at the beginning of the study (baseline) and at follow-up (during the 6 months after achieving a steady dose of the drug in an open label study) by the patient.

Results

Results from the study show that complex partial seizure frequency decreased from 25 to 15 per month. Mean combined seizure frequency decreased from 32 to 20 per month with an absolute decrease in 37, unchanged in 1 and worsened in 4. Among the 7 who did not continue in an open label study, 5 improved. 1 was unchanged and 1 worsened.

“It’s not surprising that patients would have a decrease in seizure frequency on an experimental drug. However, what may be surprising is that even the patients not on experimental drug showed a reduction in seizure frequency,” said Fountain. He attributes this to the fact that clinical trial patients receive careful evaluation, attention, extensive diagnostic testing, frequent clinic visits and form a close relationship with the drug study coordinator. Fountain believes the most important implication from this study is that patients with epilepsy benefit from participation in clinical trials. Fountain also contends, “I think the lesson for clinicians is that we may need more resources devoted to patient care such as increased frequency of clinic visits, closer case management and longer visits. Epilepsy patients probably get more attention than some others but we can do even better.” He hopes this study will dispel some of the misconceptions regarding clinical trials and will encourage epilepsy patients to participate.

For more information regarding the study you may contact Dr. Nathan Fountain at NBF2@Virginia.edu.

The abstract of this study is published in Epilepsia, 2004, Vol. 45, Supplement 7, p.144