Nearly 3 million people in the United States and 65 million people worldwide have epilepsy, a neurological condition which affects the nervous system and causes seizures. One in 26 people will develop epilepsy at some point in their lifetime, with 150,000 new cases annually in the United States. Nearly 80% of the people with epilepsy live in low- and middle-income countries and three-quarters of these individuals do not get the treatment they need.
Among those living with epilepsy, nearly one-third have ongoing seizures despite existing therapies. Each year, more than 1 out of 1,000 people with epilepsy die from sudden unexpected death in epilepsy (SUDEP). If seizures are uncontrolled, the risk of SUDEP increases to more than 1 out of 150. SUDEP is the leading cause of death in young adults with uncontrolled seizures.
In order to accelerate the identification of effective treatments for SUDEP, the Epilepsy Foundation SUDEP Institute is sponsoring a Reduction to Practice Challenge to develop a predictive biomarker or panel of biomarkers to identify people at risk for SUDEP or seizures that compromise cardiac or respiratory function. The biomarker(s) must serve as an endpoint or surrogate endpoint that will drive human SUDEP interventions. For example, the biomarker(s) may identify a high risk patient group that could be used to test existing candidate interventions such as seizure detection devices.
Milestone 1 requires a detailed Project Plan of the proposed solution. Milestone 2 involves the production of proof-of-concept data. Milestone 3 requires results that demonstrate the predictive efficacy of the biomarker(s). The SUDEP Institute intends to make up to 10 awards from a total award pool of $100,000 for Milestone 1, up to 4 awards of $25,000 each for Milestone 2, and a final award at least $800,000 for successful completion of Milestone 3.
Solvers are encouraged to enter this Challenge even if they were not involved in The SUDEP Institute Challenge: Predictive Biomarkers of Epilepsy – Challenge 9933719. Participants from the previous Challenge may elect to expound upon their (winning) solution or pursue another idea. Solvers should note that the Center for SUDEP Research (CSR) is an NIH-funded research collaborative studying animal models of SUDEP and epilepsy patients who may be at high risk for SUDEP. Solvers may contact the CSR at firstname.lastname@example.org to request data and/or biospecimens to be used in the execution of a Solution. Another resource that Solvers may access is through the North American SUDEP Registry.
This is a Reduction to Practice Challenge that requires written documentation, experimental proof-of-concept data, and biomarker validation data.
Identifying biomarkers to predict SUDEP represents a major unmet medical need. Although there are several postulated causes of SUDEP, who is at risk of mortality from epilepsy and how to prevent it remains a mystery. Emerging research shows that SUDEP can be caused by physiological changes after seizures that depress brain activity and can impair respiratory and cardiac function. SUDEP usually occurs within an hour of one or more convulsive seizures.
There are few interventions that reliably predict and prevent SUDEP in people with epilepsy. Therefore, the Epilepsy Foundation SUDEP Institute desires the development of clinically relevant, specific and sensitive biomarkers of SUDEP and near-SUDEP to facilitate the development of a therapeutic intervention for people at high risk. Biomarkers may be genetic, structural, metabolic, physiological, or another modality. An ideal biomarker or biomarker panel will be easily and safely measured, cost-efficient to detect, modifiable with intervention, and consistently associated with SUDEP or near-SUDEP and will drive human SUDEP interventions. The Epilepsy Foundation SUDEP Institute recognizes that the severity and frequency of seizures (particularly convulsive seizures) is currently the leading risk factor for SUDEP, therefore a biomarker or biomarker panel that can be predictive of seizures that compromise cardiac or respiratory function will also be considered.