Although a number of antiepileptic drugs have been approved for use in the last decade and a half, an estimated 30% or more of patients with epilepsy continue to experience uncontrolled seizures. Possibly another 30% experience significant side effects from these medications that impact their quality of life. To improve care for patients with epilepsy, it is critically important to discover new and effective therapies as rapidly as possible. The Consortium members believe the key to success in this area is the creation of a clinical research enterprise within an environment containing enabling resources. The Consortium will streamline the processes for determining the potential impact of new therapies, and reduce the organizational and regulatory barriers that hinder investigators and patients from carrying out this type of research. The Consortium aims to accomplish these goals as follows:
Creation of innovative trial designs, particularly as they relate to early, proof of principle studies that can rapidly distinguish a potentially safe and effective therapy while eliminating inactive candidates at the earliest stage of development.
- The Epilepsy Study Consortium, in collaboration with the advisory board has developed several proof of principle protocols which are available to clients.
- All of the Epilepsy Study Consortium clinical sites consist of highly specialized epilepsy programs with large outpatient affiliated practices. There are frequent meetings and interactions between coordinators, leading to optimization and harmonization of recruitment techniques and procedures between sites.
- The members of the Consortium are world renowned experts in antiepileptic drug therapeutics and various aspects of clinical trial design and statistics. These individuals can be rapidly mobilized to function as an expert advisory board to provide direction to sponsors.