Development of new therapies in epilepsy remains vital, despite the availability of a number of new treatments over the last two decades. Despite the fact that the drug development process for new epilepsy therapeutics has been well delineated, there is a great opportunity for advancement. These advances may take one of the following forms:
- Development of novel proof of principle trial designs, which will identify compounds that will have a competitive advantage in efficacy, safety, ease of use, or spectrum of activity.
- Improvement in phase II and III trial designs, leading to speed and efficiency
- Development of trial designs for specific epilepsy syndromes and populations
- Improved recruitment
Why this Consortium?
The Epilepsy Study Consortium is a unique collaboration of Investigators and foundations interested in the improvement of epilepsy patients’ lives. This collaboration has produced essential resources that can be brought to bear in partnering with industry to advance new therapies.
- The 26 epilepsy centers and their affiliate hospitals represent a large and diverse patient population, including adults and children
- The Consortium is collaborating with the Australian Epilepsy Clinical Trials Network
- The President of the consortium has been involved in epilepsy drug development for over a decade, including chairing a biennial symposium on epilepsy drug development, and is responsible for developing the only new trial design that has been accepted by the FDA for obtaining monotherapy approval
- The Consortium is sponsored by the Epilepsy Therapy Development Project, a non-profit foundation that sponsors the website Epilepsy.com. This website is now the most visited site by epilepsy patients. The website is a resource for identifying study patients
Pharmaceutical companies who choose to work with The Epilepsy Study Consortium can expect the following value added services:
- Budget development
Decreases time involved in negotiation process
- Assist with the regulatory submission package
Reduces the amount of time and effort required to start up the study
- On-site training may be provided
Improves consistency among sites, enhancing quality of the data
- Consortium will focus on recruitment strategies and tactics
Frequent meetings via conference calls increase interaction between the sites and facilitate meeting enrollment goals.
- Development of source documents and case report forms
Will design documents using templates that were successful in the past
- Each site specializes in epilepsy and has a rather large patient population
Enables careful patient selection, meet recruitment goals within the timeline
- Educational Tools
Seizure Identification Videos
Interactive Online Quiz
Seizure Identification Forms
Diagnostic Screening Forms
The Epilepsy Study Consortium is a 501 c (3) non-profit organization. Grants and study funding from the Consortium may not be used for indirect costs or institutional overhead, or the purchase of permanent equipment that exceeds 10% of the budget without prior approval. Funds may only be used for direct costs. Funds may not be allocated for travel or administrative purposes.