CURE promotes collaborative research that advances the search for a cure for epilepsy, and addresses the goal of “no seizures, no side effects.” For this initiative, CURE seeks to fund investigators focused on finding a cure for infantile spasms. Both basic scientists and clinicians are encouraged to apply.

* CURE will hold two 1-hour teleconferences to clarify the goals of this RFA and answer questions. Interested investigators are requested to RSVP by email to Julie@CUREepilepsy.org. Please specify which date you plan to participate.

Infantile Spasms Award

Letter of Intent Guidelines

The most common treatments include hormones (ACTH), steroids (prednisone), or antiepileptic drugs (especially vigabatrin). Unfortunately, there remains a lack of consensus regarding the best initial therapeutic approach. Complete control of spasms can lead to improved long-term outcome; however, currently available treatments are not always effective and are often associated with substantial adverse effects.

PURPOSE
CURE issues this directed Request for Applications (RFA) to accelerate the understanding of infantile spasms and advance a new, disease-modifying therapy into the clinic. This program will fund milestonedriven proposals for 1-3 years.

Studies appropriate for this RFA include, but are not limited to:

• Studies that will lead to the identification of a biomarker that tracks with, and is predictive of, improved clinical outcome.
• The development and characterization of animal models of IS that can be utilized in parallel with existing models in the early evaluation of potential therapeutics for the treatment of IS.
• Studies aimed at elucidating the underlying pathophysiology of IS at the molecular and genetic level.
• Back translation of proposed and new therapeutic targets identified from clinical investigations that might guide the development of novel therapies.
• Proof-of-principle preclinical studies that aim to demonstrate disease-modification.

Any proposal utilizing an animal model or proposing to develop a new animal model should discuss:

• The extent to which the proposed model is clinically relevant.
• The benefits that the new model provides over currently available models.
• Whether any observed phenotypic or electrographic features are spontaneous or evoked and if their age of onset is consistent with the human condition.
• Whether there is evidence of cognitive dysfunction.
• The extent to which the proposed model is sensitive to, or insensitive to, ACTH and/or vigabatrin.

FUNDS AVAILABLE
CURE will commit up to $5 million over the next 3 years to fund proposals submitted for this initiative. CURE intends to fund multiple proposals as a part of this initiative. Applicants may request project periods of 1-3 years for direct costs appropriate and justifiable for the work proposed. Each item and its cost must be clearly described in the budget. A maximum of $1,000 ($1,500 for international applicants) per year can be budgeted for travel to scientific meetings. CURE encourages all awardees to attend the annual American Epilepsy Society meeting. Multi-year support is not automatic for any award and is contingent upon meeting milestones and progress reports being favorably reviewed.

ELIGIBILITY CRITERIA
Applications may be submitted by investigators exploring cutting-edge approaches to biomarker and model development that will aid in the identification and development of a disease modifying therapy or cure for IS. Applicants need to be willing to work in a milestone-driven ‘team’ environment. Applications are welcomed and encouraged from collaborative teams comprised of multiple investigators. International applicants are welcome. Post-doctoral fellows are not eligible to apply as principal investigators. Researchers who serve on CURE’s Scientific Advisory Board are ineligible to apply for, or sponsor, a grant for the duration of their term. All materials must be submitted in English.

REVIEW PROCESS
There are two stages to the CURE review process: Letter of Intent and Full Proposal.

Letter of Intent
All applicants must submit a Letter of Intent (LOI). The LOI should provide a brief description of the research plan that succinctly outlines the hypothesis to be tested, the specific aims, and proposed milestones that will serve to measure progress. LOIs should specifically address the purpose of this RFA as outlined above. All LOIs will be subjected to a review process. Scientific reviewers and the CURE Research Review Board will make recommendations to the CURE Board of Directors regarding which full proposals to invite. Only a subset of applicants will be invited to submit full proposals.

LOIs will only be accepted through the proposalCENTRAL online application system (https://proposalcentral.altum.com). New users must register and fill out a professional profile before continuing on to the application process. Hard copies of LOIs will not be accepted.

Full Proposal
Applicants will be notified as to whether they have been invited to submit a full proposal. CURE will work with invited applicants to discuss key issues and feedback received during the LOI review process to help develop a clear and focused proposal. Full proposals will be accepted through the proposalCENTRAL online application system.

EXPECTATIONS
Milestones
In consultation with CURE staff, applicants will develop time-dependent milestones to ensure completion of study objectives. Investigators will be expected to interact with CURE staff and advisors regularly to discuss the project and progress against milestones. Budgets should be structured and allocated in accordance with these milestones. Continuation of funding will be contingent upon meeting milestones.

Collaboration
One of the goals for this initiative is for all funded laboratories to function as part of a collaborative team focused on a common goal: finding a cure for infantile spasms. As such, awardees will be expected to share data and progress with each other through regularly scheduled conference calls. Additionally, awardees will be expected to attend scheduled assessment meetings. These meetings will function to report on progress, exchange information with other awardees, explore potential collaborations, and identify opportunities that would enhance the productivity of all grantees or the field-at-large.

INQUIRIES
Questions regarding this RFA are welcome. All inquiries should be directed to Julie Milder at
Julie@CUREepilepsy.org or (312) 255-1801.

For questions, please contact Julie Milder at the CURE office, 312.255.1801, or email julie@cureepilepsy.org.

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