Complementary treatment approach to epilepsy

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DESCRIPTION (provided by applicant): The candidate, Dr. Siegward Elsas, seeks funding for a Mentored Patient-Oriented Research Career Development Award to obtain the skills as an independent clinical researcher in the area of CAM in epilepsy. During the five-year training period, Dr. Elsas will conduct a clinical trial of a botanical treatment for epilepsy. The clinical trial will evaluate the safety and efficacy of a botanical treatment of epilepsy. The popular botanical Passionflower is commonly used by epilepsy patients. Passionflower flavonoids have been found to prevent pentylenetetrazol-induced seizures and to activate inhibitory GABA currents in animal models. Aim 1: Test the hypothesis that Passiflora is an effective botanical treatment for epilepsy. Passiflora incarnata extracts will be analyzed for flavonoid content at the pharmacognosy laboratory at Oregon Health and Science University (OHSU), and will then be retested for their dosage range of anticonvulsant activity in a series of animal models by the NIH anticonvulsant screening program. Flavonoid-standardized Pass/flora incarnata extracts will be tested for their effectiveness in reducing seizure frequency in partial epilepsy patients in a randomized placebo-controlled phase II clinical trial. We will also test if flavonoid-standardized Passiflora incarnata extracts are effective in reducing anxiety in epilepsy patients in the randomized placebo-controlled clinical trial using standardized anxiety scales. Aim 2: Test the hypothesis that Passiflora is a safe botanical treatment of epilepsy. Safe dosing and possible direct side effects of Passiflora extracts will be tested by ECG, hematological and liver function testing in a small phase I clinical trial and again in the phase II trial. Possible interactions of Passiflora extracts with anticonvulsant metabolism will be examined by closely following patient anticonvulsant levels in the phase II clinical trial. Possible potentiation of sedative anticonvulsant side effects by Passiflora extracts will be examined by cognitive testing and questionnaires in the phase II clinical trial. During the period of the award, Dr. Elsas will pursue training towards a Master's degree in clinical investigation in the Human Investigations Program at OHSU. He will learn to conduct clinical trials and to apply biostatistics. Dr. Elsas will learn about CAM in general, about pharmacognosy, and about the regulatory environment for botanicals including the application process for an IND. In all aspects of his training, Dr. Elsas will be supervised by his mentor Barry Oken, director of the Oregon Center for Complementary and Alternative Medicine in Neurological Disorders at OHSU. At the end of the award period, Dr. Elsas will have completed a clinical trial of a botanical and will be well positioned to obtain independent research funding.