DOD Multiple Sclerosis Pilot Clinical Trial Award

Post Date

April 15th 2016

Application Due Date

August 29th 2016

Funding Opportunity Number

W81XWH-16-MSRP-PCTA

CFDA Number(s)

12.420

Funding Instrument Type(s)

Cooperative Agreement
Grant

Funding Activity Categories

Science and Technology and other Research and Development

Number of Awards

2

Eligibility Categories

Unrestricted

Funding

• Estimated Total Funding:

  $1900000

• Award Range:

  $0 - $0

Grant Description

The MSRP PCTA mechanism was first offered in FY15. In FY15, 25 PCTA applications were received, and 3 were recommended for funding. The PCTA supports early-phase, proof-of-principle clinical trials to investigate hypothesis-based, innovative interventions that have the potential to result in a profound impact on the management of MS symptoms. While therapeutic approaches proposed for testing through the PCTA must represent novel, hypothesis-based approaches for treating MS symptoms, they may include therapies already in clinical use, or undergoing clinical testing for other diseases, provided that their proposed use for MS would lead to a major advancement for treating one of the disease symptoms. It is anticipated that outcomes from studies funded by this award will provide scientific rationale for subsequent development of larger, efficacy-based clinical trials of interventions that will transform MS patient care. Funding from the PCTA must support a clinical trial and cannot be used for preclinical research or correlative studies. This mechanism supports pilot clinical trials encompassing Phase 0, Phase I, or Phase II for drugs or drug combinations, Class II or III for devices, or other types of trials that conduct early clinical testing of innovative approaches for MS symptoms. A clinical trial is defined as a prospective accrual of patients where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project addressing MS Symptoms should consider the Exploration - Hypothesis Development Award (Funding Opportunity Number: W81XWH-16-MSRP-EHDA). The term Яhuman subjectsН is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed pilot clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.

Contact Information

• Agency

  Department of Defense

• Office:

  Dept. of the Army -- USAMRAA

• Agency Contact:

  CDMRP Help Desk
  301-682-5507
  help@eBRAP.org

• Agency Mailing Address:

  CDMRP Help Desk

• Agency Email Address:

  help@eBRAP.org