This DoD grant aims to advance innovative research on Tuberous Sclerosis Complex (TSC) pathogenesis and manifestations, improving the lives of affected individuals. The Tuberous Sclerosis Research Pilot Clinical Trial Award specifically supports initial studies of interventions (e.g., drugs, devices) to gather preliminary data for future clinical trials. Research should focus on areas such as genetic modifiers, preclinical models, biomarkers, adult manifestations, mTOR inhibitors, novel diagnostic/treatment strategies, and understanding TSC-associated neurological conditions, including epilepsy and neurocognitive disorders. Pilot studies encompass identifying target populations, optimal dosages, feasibility, efficacy, and safety.
Opportunity ID: 233121
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-13-TSCRP-PCTA |
| Funding Opportunity Title: | DoD Tuberous Sclerosis Research Pilot Clinical Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Regional Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 03, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jul 11, 2013 |
| Current Closing Date for Applications: | Jul 11, 2013 |
| Archive Date: | Aug 10, 2013 |
| Estimated Total Program Funding: | $640,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | The mission of the TSCRP is to encourage innovative research aimed at understanding the pathogenesis and manifestations of TSC to improve the lives of individuals with TSC. Within this context, the FY13 TSCRP encourages applications that address one or more of these vital program Focus Areas: Genetic, epigenetic, and non-genetic modifiers of TSC. Preclinical models and therapeutic strategies (e.g., cytotoxic agents, combination therapies). Biomarkers for early detection, prognosis, and prediction of treatment outcomes (such as serum markers, imaging, electrophysiology, prenatal testing, and pharmacogenetics). Impact of TSC manifestations in adults (e.g., care management, age-specific pathogenesis, epidemiology, renal, reproductive issues, and lymphangioleiomyomatosis [LAM]). Long-term benefits and effects of mTOR inhibitors or other agents. Novel strategies for diagnosis, treatment, and prevention of TSC manifestations including those geared toward early identification and intervention. Cellular and molecular mechanisms of TSC and LAM pathogenesis. Causes and treatment of epilepsy in TSC. Causes and treatment of TSC-associated neurocognitive disorders including cognitive impairment, and psychiatric, behavioral, and sleep disorders. The TSCRP Pilot Clinical Trial Award mechanism supports studies of interventions (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) with the potential to have a major impact on the treatment or management of TSC. Funding from this award mechanism must support a pilot study aimed at obtaining preliminary data to support the rationale and design of subsequent clinical trials. Examples of research topics include but are not limited to the following: Studies to identify an appropriate population. Studies to identify the dosage, duration, and/or delivery strategy of the intervention. Studies to evaluate the feasibility of the intervention in TSC. Studies to better understand efficacy and safety. Pilot clinical trials may include exploratory studies involving limited human exposure that produce diagnostic or therapeutic information (e.g., screening studies, microdose studies), toxicity studies of an intervention, and studies to determine the mechanism of action and side effects of an intervention. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
CDMRP Help Desk
301-682-5507 help@cdmrp.org Email:help@cdmrp.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 233121 Full Announcement-1 -> tscrp_fy13 pcta ind documentation form_gg.pdf
Folder 233121 Full Announcement-1 -> tscrp_fy13 pcta pa_gg.pdf
Packages
| Agency Contact Information: | CDMRP Help Desk 301-682-5507 help@cdmrp.org Email: help@cdmrp.org |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 12.420 | PKG00176399 | May 02, 2013 | Jul 11, 2013 | View |
Package 1
Mandatory forms
233121 RR_SF424_1_2-1.2.pdf
233121 PerformanceSite_1_4-1.4.pdf
233121 RR_Budget-1.1.pdf
233121 RR_KeyPersonExpanded_1_2-1.2.pdf
Optional forms
233121 RR_SubawardBudget30-1.2.pdf
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