DoW Multiple Sclerosis Clinical Trial Award | HT942526MSRPCTA

FY26 Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA) FAQs

What is the FY26 MSRP Clinical Trial Award (CTA)?

The FY26 Multiple Sclerosis Research Program (MSRP) Clinical Trial Award (CTA) is a discretionary grant opportunity from the U.S. Department of the Army (administered through USAMRAA) intended to move multiple sclerosis (MS) clinical trials into action quickly, with an emphasis on trials that could meaningfully change MS treatment or management.

Who is offering and administering this grant opportunity?

This opportunity is offered by the U.S. Department of the Army and administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA).

What is the Funding Opportunity Number (FON) and CFDA listing?

The Funding Opportunity Number is HT942526MSRPCTA and the CFDA number is 12.420.

What is the main purpose or goal of this award?

The goal is to support interventional clinical research in MS and to accelerate well-justified clinical trials that are positioned to improve real-world MS care, treatment, or management.

Is this award meant for early discovery or basic research?

No. The program is oriented around interventional clinical research and is meant to support trials that test potentially impactful approaches rather than early discovery work.

Do proposed projects have to align with specific focus areas?

Yes. Projects must align with at least one of the program's FY26 CTA focus areas. Applicants are expected to explicitly state which focus area(s) they are addressing and justify the alignment.

What kinds of clinical trials and interventions can be supported?

The CTA can fund MS clinical trials across a range of intervention types as long as the trial is positioned to improve MS care. Supported evaluations may include new products, pharmacologic agents (including drugs and biologics), medical devices, clinical guidance, and emerging approaches or technologies.

Is the program limited to one treatment modality (for example, only drugs)?

No. The opportunity is structured to accommodate both therapeutic and management-focused interventions, provided the proposed trial is well-justified and relevant to MS populations.

How many funding levels are available under the CTA?

There are two funding levels: Funding Level 1 (CTA-FL1) and Funding Level 2 (CTA-FL2). These correspond to different stages and scales of clinical testing.

What is Funding Level 1 (CTA-FL1) intended to support?

CTA-FL1 is aimed at smaller proof-of-principle trials such as pilot studies, first-in-human efforts, or phase 0 trials. The purpose is typically to demonstrate feasibility, generate early signals, and/or produce practical information needed to design a larger trial.

Does CTA-FL1 require preliminary data?

Yes. Even though FL1 supports earlier and smaller trials, it is not intended for speculative proposals. Applicants must include preliminary data relevant to the proposed clinical trial.

What is Funding Level 2 (CTA-FL2) intended to support?

CTA-FL2 supports larger phase 1 or phase 2 clinical trials intended to provide preliminary evidence of safety and/or efficacy in appropriate MS patient populations.

What level of trial planning detail is expected for CTA-FL2 applications?

FL2 applications are expected to include a more fully developed clinical trial plan with clear rationale for core design choices, including the intervention type, participant follow-up duration, proposed sample size, outcome measures (clinical and/or paraclinical), assessment tools, and assessment frequency.

Does CTA-FL2 require preliminary data in MS populations?

Yes. Preliminary data are required, and for FL2 they must be relevant to the proposed clinical trial in MS populations, supporting that the intervention and approach have a credible basis for clinical testing in MS.

What does the announcement mean by "Regulatory Agency"?

In this announcement, "Regulatory Agency" means the U.S. Food and Drug Administration (FDA) or another applicable international regulatory authority, depending on where and how the clinical trial is being conducted.

Why does the "Regulatory Agency" definition matter for applicants?

It matters because clinical trials, especially those involving drugs, biologics, or devices, may require regulatory interaction and compliance steps. Applicants should be prepared to position their trial appropriately within the applicable regulatory context.

What is the eligibility for this grant opportunity?

Eligibility is listed as unrestricted, meaning a wide range of applicant organizations may apply.

When is the application closing date?

The original closing date is August 13, 2026.

How many awards are expected to be made?

The program anticipates making about three awards.

Is there an award ceiling (maximum budget) listed in the provided information?

No. The provided excerpt does not specify an award ceiling. Applicants typically need to consult the full funding announcement for maximum budget limits under each funding level and any cost, duration, or spending constraints.

Is this a discretionary grant?

Yes. The opportunity is described as a discretionary grant.

What should applicants be prepared to justify in their application?

Based on the provided description, applicants should be prepared to (1) explicitly identify and justify alignment with one or more FY26 CTA focus areas, (2) justify that the trial is an interventional clinical study positioned to improve MS care, and (3) provide preliminary data relevant to the proposed MS clinical trial. For FL2, applicants should also justify major design elements such as sample size, outcomes, assessment schedule, and participant follow-up duration.