DoD Tuberous Sclerosis Complex Pilot Clinical Trial Award

Post Date

May 6th 2015

Application Due Date

July 27th 2015

Funding Opportunity Number

W81XWH-15-TSCRP-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:

  $960000

• Award Range:

  $None - $None

Grant Description

The PCTA mechanism supports exploratory studies involving limited human exposure that produce diagnostic or therapeutic information, safety, and tolerability studies and studies to determine the mechanism of action. These studies should be aimed at obtaining preliminary data leading to the development of interventions, as well as clinical biomarkers, with the potential to improve TSC outcomes. Preclinical studies will not be supported by this mechanism. Examples of acceptable studies include but are not limited to the following: ╢ Identification of an appropriate population for the proposed study. ╢ Identification of the dosage, duration, and/or delivery strategy of an intervention. ╢ Evaluation of the feasibility of the intervention in TSC. ╢ Development of clinical biomarkers or outcome measures for future clinical trials. ╢ Evaluation of efficacy and safety. If the clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) must be submitted to the FDA prior to the application submission deadline. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA prior to the application submission deadline, or that the device is exempt from an IDE, is required. Documentation of approval or exemption of the IND or IDE prior to programmatic review must be obtained and submitted to the CDMRP Help Desk (help@eBRAP.org), otherwise the Government reserves the right to withdraw the application

Contact Information

• Agency

  Department of Defense

• Office:

  Dept. of the Army -- USAMRAA

• Agency Contact:

  CDMRP Help Desk
  Phone: 301-682-5507
  

• Agency Mailing Address:

  CDMRP Help Desk

• Agency Email Address:

  help@eBRAP.org