DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award

Background
The FY23 ALSRP Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of Amyotrophic Lateral Sclerosis (ALS). The ALSRP was initiated in FY07 to provide support for research of exceptional scientific merit. The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.

Grant Details
Projects may range from phase 1 to small-scale phase 2 trials and should aim to de-risk and inform the design of more advanced trials by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations.

Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preliminary studies and/or preclinical data. Applications submitted to this award can have outcomes that focus on specific subpopulations of ALS patients or potentially even individual patients. Applicants not investigating a therapeutic but proposing a clinical trial to optimize established ALS clinical care must submit under a lower total direct cost Clinical Care Tier.

Eligibility Requirements
All organizations, including foreign organizations, foreign public entities, and international organizations, are eligible to apply. Government Agencies Within the United States: Local, state, and federal government agencies are eligible to the extent that applications do not overlap with their fully funded internal programs. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY23 ALSRP program announcements being offered.

Period of Performance
The anticipated direct costs budgeted for the entire period of performance for a Standard FY23 ALSRP Pilot Clinical Trial Award should not exceed $2M. The anticipated direct costs budgeted for the entire period of performance for an FY23 ALSRP Pilot Clinical Trial Award – Clinical Care Tier should not exceed $1M. Awards will be made no later than September 30, 2024.

Grant Value
$8M is expected to fund approximately three Pilot Clinical Trial Award applications. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY23 funding opportunity will be funded with FY23 funds, which will expire for use on September 30, 2029.