NeuroNEXT

We are pleased to announce the continuation of the NINDS Clinical Trials Methodology Course (CTMC). We are currently accepting applications for the 2024 cohort. The overarching goal of the CTMC is to help investigators develop scientifically rigorous, yet practical clinical trial protocols. Our focus is on investigators who have not previously designed their own prospective, interventional clinical trials.  Applicants proposing large, multi-center trials will also be considered this year. The multi-center proposals should ideally be aligned with the focus areas of one of the established NINDS clinical research networks. Please see application instructions for more information.

Course

There is a combination of distance learning activities and a REQUIRED residential course, along with small group mentorship from experienced clinical trialists and biostatisticians. The residential part of the course will be held June 3^rd – 6^th in Charlottesville, VA. Funding for travel (within the US) and accommodations will be provided for participants.

Who Should Apply?

Qualified applicants from clinical disciplines focused on neurological disease or injury (including, but not limited to pediatric and rare diseases), along with biostatisticians working on projects with clinical neuroscience researchers should apply. All preliminary trial ideas are encouraged, but it is REQUIRED that protocols be focused on the clinical neurosciences. Trainees should have content area mentors to assist them with the science and implementation of their project. A small number of projects may qualify for additional work using clinical trial simulation.

Application

2024 Application Webpage

2024 Application Instructions

DEADLINE

The application submission deadline is March 4^th, at 9am Eastern Time. Application forms and additional details are available on the course website: https://siren.network/training/ctmc. Applications will be accepted on a rolling basis. Early applications will be considered for early acceptance.

Have Questions?

Please refer to our FAQ here. Please contact NINDS‐CTMC‐Info@umich.edu or William Meurer, MD, MS with any additional questions.

Thank you.

The NINDS Clinical Trials Methodology Course is supported by the NeuroNEXT DCC Grant Number U01 NS077352 and is administered by the University of Michigan, the University of Iowa, University of Indiana, and University of Virginia. Additional support is provided by the American Academy of Neurology.

The Annual SCT Meeting registration is now open.  This year it will be hosted in Boston, MA on 5/19- 5/22.  Please see the attached link for more details.

https://acrobat.adobe.com/link/track?uri=urn:aaid:scds:US:79c97166-8b69-3846-937f-ee224531d376

NOI for 2 new ROAs will be issued for NeuroNEXT Clinical Trials: Stage 1 Preliminary Application and Stage 2 Protocol Application will replace the current Notice of Funding Opportunity ‘NeuroNEXT Clinical Trials (U01 Clinical Trial Optional) PAR-21-223’ expiring on March 06, 2024.

NOI: https://grants.nih.gov/grants/guide/notice-files/NOT-NS-24-045.html

The ROAs for the Gene Therapy Consortium were published on December 4, 2023.  Please find the links below.  The submissions will be accepted starting on December 28, 2023 and the submission deadline is rolling.

• Ultra-rare Gene-based Therapy (URGenT) Clinical Trials Conducted within NeuroNEXT: Stage 1 Preliminary Application (OT2)

https://www.ninds.nih.gov/sites/default/files/documents/URGenT%20CT%20NN%20ROA%20Stage1_clean_508C.pdf

• Ultra-rare Gene-based Therapy (URGenT) Clinical Trials Conducted within NeuroNEXT: Stage 2 Protocol Application (OT2)

https://www.ninds.nih.gov/sites/default/files/documents/URGenT%20CT%20NN%20ROA%20Stage2_clean_508C.pdf

Dr. Francis Rossignol of hte NIH National Human Genome Research Institute (NHBRI) will present as part of theGNEM Symposium Speaker Series presented by the Neuromuscular Disease Foundation. His talk, entitled “ManNAc As A Potential Therapy for GNE Myopathy – Advances and Future Directions” will include discussion of NN109. This talk is free of charge and available virtually. More information can be found at this link: https://ndf.ticketspice.com/2022-ndf-speaker-series-with-francis-rossignol

The RFAs for the network renewal were published on September 20, 2022. Please find links below. The deadline for grant submissions is November 21, 2022.

• Site RFA at the following link: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-22-031.html
• CCC RFA at the following link: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-22-029.html
• DCC RFA at the following link: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-22-030.html

Please note that there has been a notice of correction published related to the site RFA: https://grants.nih.gov/grants/guide/notice-files/NOT-NS-23-028.html

NN106 CYTO-C Prospective biomarker study results have been published in Neurooncology Advances.  

Results of the NN103 study were cited in NeurologyLive.  

The results of the NN103 Beat MG have been posted online at the American Academy of Neurology.  

Congratulations to Dixie Ecklund, Director of Operations at the NeuroNEXT DCC, for being selected to join the Society for Clinical Trials Class of 2021 Fellows! Ecklund will be recognized as a new inductee at the virtual SCT annual meeting in May.