DoD Multiple Sclerosis Pilot Clinical Trial Award | Apply Online

Opportunity Summary:

The DoD Multiple Sclerosis Pilot Clinical Trial Award (PCTA), funding opportunity number W81XWH 15 MSRP PCTA, is a FY15 program from the Department of the Army (USAMRAA) under the Congressionally Directed Medical Research Programs. It was introduced for the first time in FY15 as a mechanism specifically designed to push promising, symptom-focused multiple sclerosis ideas into early human testing. The central goal is to fund early-phase, proof-of-principle clinical trials that are hypothesis-driven and genuinely innovative, with a clear line of sight to improving how MS symptoms are managed in real patients. The program is positioned as a bridge between concept and larger trials, with the expectation that results from these projects will generate the scientific justification for later, larger efficacy studies that could materially change MS patient care.

This award is focused on clinical trials that test interventions in people, prospectively, with measurable outcomes tied to exploratory findings, safety, effectiveness, and/or early efficacy. The announcement uses a broad definition of “intervention,” which can include drugs, biologics, devices, surgical procedures, rehabilitation approaches, behavioral interventions, or other modalities, as long as they are tested directly in human subjects and outcomes represent a direct effect of the intervention or interaction. Importantly, the PCTA is not meant for preclinical work, and it also does not support stand-alone correlative studies under this mechanism. Investigators who are still in the preclinical stage are directed instead to the MSRP Investigator Initiated Research Award (W81XWH 15 MSRP IIRA).

In terms of what kinds of trials qualify, the PCTA supports Phase 0, Phase I, or pilot Phase II trials for drugs or drug combinations, and Class II or Class III device trials, along with other early clinical testing approaches aimed at MS symptoms. The program explicitly encourages “outside the box” concepts, including repurposing therapies already used or being tested in other diseases, but only when the proposed MS use would represent a major step forward in treating a specific symptom of the disease. The emphasis is on symptom management rather than general disease modification, and on interventions that could plausibly deliver a profound impact if the early signal holds up.

The program gives examples of the types of questions these pilot trials can address. These include identifying and validating an appropriate participant population for the study, figuring out practical elements like dosage, duration, and delivery strategy, testing feasibility in an MS setting, and evaluating early safety and efficacy. In other words, these projects should reduce key uncertainties that commonly block progress to larger trials, while still being tightly grounded in a testable scientific hypothesis.

Several submission and readiness requirements are highlighted as core to competitiveness and eligibility. A pre-application is mandatory, and full application submission is by invitation only, which means teams must clear an initial screening step before they can submit a complete proposal. Applicants are expected to include scientific rationale and/or preliminary data that is directly relevant to MS and to the proposed clinical approach, rather than relying only on general plausibility or non-MS evidence. They must also show documented access to a suitable MS patient population that is large and appropriate enough to produce a meaningful outcome for the proposed trial, not just a general statement that patients exist.

The application must also lay out a credible “next steps” plan: a clear description of how the team will advance the intervention to the next development stage after the award ends. This reflects the program’s intent to fund trials that are not dead ends, but instead are designed to set up larger, efficacy-oriented studies if results justify it. Regulatory readiness is another key point. If the intervention requires an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), the approval must be in place before an award will be made. Finally, the program expects speed and execution: funded clinical trials are expected to begin within six months of the award date, reinforcing that these are meant to be launch-ready studies rather than long lead-time development efforts.

From an administrative standpoint, this opportunity was offered as a cooperative agreement and/or grant under CFDA 12.420 (Military Medical Research and Development). It was posted April 28, 2015, with an original and final closing date of September 10, 2015, and an archive date of October 10, 2015. The estimated total funding listed was $2.9 million, with an anticipated three awards. The opportunity stated no cost sharing or matching requirement, and eligibility was described as unrestricted, meaning it was broadly open to many entity types, subject to any additional eligibility clarifications in the full text. For assistance accessing the full announcement, the contact listed was the CDMRP Help Desk at 301-682-5507.

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Previous opportunity: DoD Multiple Sclerosis Investigator Initiated Research Award

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