The MSRP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of multiple sclerosis. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.
The FY24 MSRP CTA offers two funding levels (Refer to Section II.D.5, Funding Restrictions). Only one funding level may be chosen per application and the choice of application category is at the discretion of the applicant. The requested budget at each funding level must be justified and appropriate to the scope of the clinical trial proposed. The following are generalized descriptions of the scope of research appropriate for each funding level:
• Funding Level 1 (CTA-FL1) supports small-scale, early-phase, proof-of-principle clinical trials to demonstrate feasibility or inform the design of more advanced trials, or other clinical trials that are appropriate for this funding level. Preliminary data relevant to the proposed clinical trial, preferably in subjects with MS, are required.
• Funding Level 2 (CTA-FL2) supports larger-scale clinical trials at phase 1 or phase 2 that seek to show preliminary evidence of safety or efficacy (i.e., benefit of clinical or paraclinical outcomes) in relevant patient populations. Strong justification should be provided, which could include, but is not limited to, intervention type, trial duration, sample size, outcome measures, assessment tools, and frequency of assessment. Preliminary data relevant to the proposed clinical trial, preferably in subjects with MS, are required.
Deadlines:
• Required Pre-Application Deadline: June 10, 2024
• Invitation to Submit an Application: July 2024
• Application Submission Deadline: October 7, 2024
To meet the intent of the funding opportunity, all applications submitted to the FY24 MSRP Clinical Trial Award (CTA) program announcement must address one or both of the following Focus Areas:
• Promoting Repair, Neuroprotection, and Remyelination in Multiple Sclerosis
• Treatment of Multiple Sclerosis Symptoms
The PI named on the application must be an independent investigator at or above the level of Assistant Professor (or equivalent). An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by or affiliated with an eligible organization.
The anticipated total (including direct costs and indirect costs budgeted for the entire period of performance for an FY24 MSRP CTA should not exceed $2M (CTA-FL1) or $4M (CTA-FL2). Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
