Proposal for a "phase II" multicenter trial model for preclinical new antiepilepsy therapy development

O'Brien, T. J. (author)

Ben-Menachem, Elinor, 1945 (author): Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap och rehabilitering,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience and Rehabilitation

Bertram, E. H. (author)

Collins, S. D. (author)

Kokaia, Merab (author): Lund University,Lunds universitet,Wallenberg Neurocentrum, Lund,Medicinska fakulteten,Wallenberg Neuroscience Centre, Lund,Faculty of Medicine

Lerche, H. (author)

Klitgaard, H. (author)

Staley, K. J. (author)

Vaudano, E. (author)

Walker, M. C. (author)

Simonato, M. (author)

(creator_code:org_t)

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Abstract Subject headings

There is a pressing need to address the current major gaps in epilepsy treatment, in particular drug-resistant epilepsy, antiepileptogenic therapies, and comorbidities. A major concern in the development of new therapies is that current preclinical testing is not sufficiently predictive for clinical efficacy. Methodologic limitations of current preclinical paradigms may partly account for this discrepancy. Here we propose and discuss a strategy for implementing a "phase II" multicenter preclinical drug trial model based on clinical phase II/III studies designed to generate more rigorous preclinical data for efficacy. The goal is to improve the evidence resulting from preclinical studies for investigational new drugs that have shown strong promise in initial preclinical "phase I" studies. This should reduce the risk for expensive clinical studies in epilepsy and therefore increase the appeal for funders (industry and government) to invest in their clinical development.

By the author/editor: O'Brien, T. J.; Ben-Menachem, El ...; Bertram, E. H.; Collins, S. D.; Kokaia, Merab; Lerche, H.; show more...; Klitgaard, H.; Staley, K. J.; Vaudano, E.; Walker, M. C.; Simonato, M.; show less...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Neurology

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