NeuroNEXT: Network for Excellence in Neuroscience Clinical Trials

NeuroNEXT: Network for Excellence in Neuroscience Clinical Trials

NeuroNEXT will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. The network includes multiple Clinical Sites, one Clinical Coordinating Center (CCC) and one Data Coordinating Center (DCC).

Network website: www.neuronext.org

You DO NOT need to be part of the NeuroNEXT infrastructure to apply to conduct a study within the network. Applications from academic investigators, advocacy groups/foundations, small businesses and the pharmaceutical industry are welcomed.

NeuroNEXT Executive Committee (NEC)

Permanent members
  • Christopher S. Coffey
  • Merit Cudkowicz
  • Robin Conwit, M.D.
Rotating members
  • Dr. John Kissel
  • Robert G. Holloway, M.D.
  • Mark Goldberg
  • Robert Fox, M.D.
  • Marianne Kearney
  • Stephen J. Kolb, M.D.
  • Dixie Ecklund
  • Richard Nowak, M.D.
  • Patrick Lyden, M.D.

Data Coordinating Center: University of Iowa

Clinical Coordinating Center: Massachusetts General Hospital

NeuroNEXT Clinical Sites: Clinical Sites


How to Apply to NeuroNEXT

NeuroNEXT is intended to facilitate the testing of novel therapeutics (drugs, biologics, devices) for neurological disorders. These novel therapeutics may come from academic investigators or directly from the biotechnology or pharmaceutical sector. NeuroNEXT aims to support scientifically sound phase 2 clinical trials that provide data for clear go/no-go decisions. Biomarker validation studies are also considered either independently or as part of a therapeutic trial.

Working with NeuroNEXT is a cooperative venture between NINDS, the NeuroNEXT network and the applicant. NINDS will provide guidance to potential applicants with input from the Office of Clinical Research (OCR), the applicable NINDS Extramural office/cluster and the NeuroNEXT Executive Committee (NEC). Potential applicants should contact NINDS OCR in order to discuss the feasibility of conducting the proposed trial through the NeuroNEXT infrastructure.

There are three mechanisms available for potential applicants:

  1. Academic investigators may apply for cooperative agreement grants: NeuroNEXT Clinical Trials (U01) (PAR-13-343).
  2. Industry may apply for expedited access to NeuroNEXT expertise and infrastructure through the NeuroNEXT Infrastructure Resource Access (X01) (PAR-15-195) under a cost-sharing arrangement and Cooperative Research and Development Agreement (CRADA) with NINDS.
  3. Small businesses may apply for cooperative agreement grants: NeuroNEXT Clinical Trials (U01) (PAR-11-343); OR through our Small Business program: NeuroNEXT Small Business Innovation in Clinical Trials (U44) (PAR-15-194).

Information for potential industry collaborators:

Information for potential advocacy collaborators:

Potential applicants whose clinical research cannot be supported through NeuroNEXT are encouraged to consider an alternate funding mechanism:

  • NINDS Exploratory Clinical Trials (PAR-13-281)
  • NINDS Phase III Investigator-Initiated Multi-Site Clinical Trials (PAR-13-278)


Referral/Review Process for NeuroNEXT Applications

  • Prospective applicant contacts NINDS/OCR to discuss the proposed trial:

Robin Conwit
Program Director, Office of Clinical Research
conwitr@ninds.nih.gov

Dr. Codrin Lungu
Program Director, Office of Clinical Research
lunguci@ninds.nih.gov

  • NINDS program staff will discuss the proposed trial
  • Trials that have good NINDS program support are referred to the NEC to assess network feasibility
  • Projects that have NINDS program support and are feasible for network performance are asked to submit a formal application for peer review by the NeuroNEXT SEP and subsequent consideration by the NINDS Advisory Council. The NeuroNEXT CCC will assist in protocol development in support of the formal application.
  • NeuroNEXT Clinical Trials (U01) - Standard dates apply for scientific merit review of applications coming under the U01 grant mechanism: for detailed information, please refer to Section V. Application Review Information in PAR-13-343.
  • NeuroNEXT Infrastructure Resource Access (X01) - Expedited dates apply for scientific merit review of applications coming under the X01 grant mechanism: for detailed information, please refer to Section V. Application Review Information in PAR-15-195.
  • NeuroNEXT Small Business Innovation in Clinical Trials (U44) - Standard dates apply for scientific merit review of applications coming under the U44 grant mechanism: for detailed information, please refer to Section V. Application Review Information in PAR-15-194.

Current NeuroNEXT-supported Studies

  • NN-101 SMA biomarkers study
  • NN-102 SPRINT-MS
    Robert J. Fox, MD, MS, FAAN is the Protocol Principal Investigator for the study “A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects with Progressive Multiple Sclerosis”.
    Multiple Sclerosis (MS) is a chronic, inflammatory demyelinating disease of the central nervous system that affects 400,000 people in the US and 2 million people worldwide. Those affected with the disease are characterized by their progression into one of three variants: relapsing-remitting, secondary-progressive and primary-progressive. Despite recent improvements in pharmacotherapy for relapsing-remitting Multiple Sclerosis (RRMS), there are no therapies with demonstrated efficacy in progressive Multiple Sclerosis in the absence of relapses.

    We are doing this research study to determine the safety, tolerability and activity of ibudilast (MN-166) administered twice daily over a 96-week period in subjects with primary and secondary-progressive multiple sclerosis. The study will be conducted by the NIH-funded NeuroNEXT Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) in NeuroNEXT sites around the United States. A total of 250 male and female subjects from 21 to 65 years old, inclusive, are planned to be enrolled into 2 treatment arms (ibudilast or matching-placebo). The trial will utilize advanced brain imaging to assess activity and correlate clinical activity with these imaging measures.

    This study is also being supported by Medicinova and the National Multiple Sclerosis Society as part of a private-public partnership with the NIH.
  • NN-103 Rituximab in Myasthenia Gravis
    Richard J. Nowak, MD, MS, is the Protocol Principal Investigator for the study “A Phase II Trial of Rituximab in Myasthenia Gravis”.

    Myasthenia gravis (MG) is an autoimmune disorder of neuromuscular transmission with an estimated annual incidence of about 1-2 per 100,000 and prevalence as high as 20-50 per 100,000. Despite current therapies a subset of patients remain medically refractory or have intolerable medication adverse effects. There is need for another agent in the management of MG as there are few effective drugs. Safe, well-tolerated, effective and steroid-sparing therapeutics are very desirable.

    The purpose of the study is to find out the effect and safety of a new use of the drug rituximab in myasthenia gravis (MG) patients who are on prednisone.
  • NN-104 Stroke
    Patrick D. Lyden, MD, Chairman of the Department of Neurology at Cedars-Sinai Medical Center, is the Protocol Principal Investigator of the study "Safety evaluation of 3K3A-APC in ischemic stroke" (NN104). Kent E. Pryor, PhD, Chief Operating Officer of ZZ Biotech, is the Principal Investigator of the X01 NeuroNEXT Infrastructure Resource Access Award. Berislav V. Zlokovic, MD, PhD, Director of the Zilkha Neurogenetic Institute at Keck School of Medicine, University of Southern California, is the Co-Investigator.

    Currently, the only approved treatment in the US for ischemic stroke is a drug called recombinant tissue plasminogen activator (rtPA or tPA), indicated for intravenous administration within three hours of onset of the stroke. The drug is designed to break down blood clots to restore blood flow to the brain and thereby prevent further damage. In some patients however, tPA can cause internal bleeding and other complications. 3K3A-APC’s cytoprotective properties may be useful in protecting ischemic brain tissue from further damage, while avoiding an increase in the chance of treatment-related bleeding.

    This research study is being conducted to determine the safety, tolerability and activity of 3K3A-APC, following the use of tissue plasminogen activator (tPA) in subjects who have experienced moderately severe acute hemispheric ischemic stroke. The study intervention will be administered as a 15-minute infusion every 12 hours for up to 5 infusions. Four dose levels will be considered for this trial. Approximately one hundred participants of age 18-80 years old will be enrolled and followed for 90 days.

Contact:

Robin Conwit, M.D.
Program Director, Office of Clinical Research
rc296d@nih.gov

Codrin Lungu, M.D.
Program Director, Office of Clinical Research
lunguci@ninds.nih.gov

Questions? Please email NEXT@ninds.nih.gov