DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award | HT9425 23 ALSRP PCTA

Opportunity Information: Apply for HT9425 23 ALSRP PCTA

The DOD Amyotrophic Lateral Sclerosis (ALS) Pilot Clinical Trial Award (FY23 ALSRP PCTA; opportunity number HT9425 23 ALSRP PCTA) is a Department of Defense funding opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA) to speed the launch of early-stage clinical trials that could meaningfully change how ALS is treated or managed. The core emphasis is on rapid, well-justified studies that generate decision-quality evidence to guide the next steps, rather than on completing a full development program within the award period. In practical terms, the program is looking for trials that reduce uncertainty and help the field move faster into larger, more definitive studies by showing whether an approach is safe, feasible, measurable with appropriate biomarkers, and suggestive of benefit in the right patient population.

Projects supported under this award typically fall in the phase 1 to small, early phase 2 range. The intent is to support trials that can answer high-value questions such as: is the intervention safe enough to continue development, can the protocol and recruitment approach work in the real-world ALS setting, do proposed biomarkers perform as expected in patients, and is there a signal of therapeutic efficacy that justifies a larger, more expensive, and more time-intensive trial. The interventions may include drugs, biologics, or devices, but they need to be backed by a strong scientific rationale and supported by preliminary clinical experience and/or solid preclinical data. The program frames "impact" as the ability of the trial results to improve and accelerate future trials (for example, by validating endpoints, identifying responsive subgroups, establishing dosing or device parameters, or demonstrating feasibility across sites), not whether the therapy is ready for widespread clinical use at the end of the project.

The opportunity also recognizes the heterogeneity of ALS and explicitly allows outcomes and designs that focus on specific ALS subpopulations, and in some cases even highly individualized approaches, provided the trial remains clinically meaningful and capable of informing subsequent research or care. This flexibility can be important for testing targeted therapies, genotype- or phenotype-informed approaches, or biomarker-defined cohorts where a one-size-fits-all trial is unlikely to be informative.

In addition to trials of new or emerging therapeutics, the announcement includes a separate pathway for studies that are not testing a novel therapeutic but are instead optimizing established ALS clinical care. These applications must be submitted under a Clinical Care Tier with a lower allowable total direct cost. The types of projects envisioned here include practical, patient-centered efforts such as improving respiratory care strategies, refining or enhancing approved devices and assistive technologies, developing or testing symptom management strategies, and evaluating telemedicine or care-delivery models. For this tier, near-term impact on patient care is a major consideration, meaning the program expects the work to be positioned to produce actionable improvements in how care is delivered or how patients are supported in the relatively immediate future.

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses grant and/or cooperative agreement mechanisms. It is listed under CFDA 12.420 and is open to an unrestricted range of applicants (meaning any entity type may apply, subject to any eligibility clarifications in the full text). The FY23 posting was created on February 8, 2023, with an original closing date of July 13, 2023. The listing indicates an expected number of awards of three, and the award ceiling is shown as 0 in the source data, which typically signals that applicants should rely on the detailed announcement for budget limits and tier-specific caps rather than the high-level summary field.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Feb 08, 2023.
• Applicants must submit their applications by Jul 13, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 3 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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