NN105 - STAIR

 

 

 

Welcome to the home of NeuroNEXT protocol NN 105 - STAIR (SRX246: Safety, Tolerability, and Activity in IRritable subjects with HD).

 

Huntington's disease (HD) is an inherited disease that results from expansion of a trinucleotide (CAG, cytosine/adenine/guanine) repeat that encodes a polyglutamine tract in the huntingtin gene and gradually damages neurons.  Overtime this cellular loss affects voluntary motor control, results in involuntary movements (chorea), and causes cognitive decline.  Psychiatric symptoms, including irritability, are commonly seen in HD, and are quite distressing for patients and their family. Preclinical pharmacology studies suggest that SRX246, a first in-class vasopressin 1a (V1a) receptor antagonist, has potential as a novel therapeutic agent for major neuropsychiatric symptoms seen in HD patients.

This research study is being conducted to test the tolerability and further examine the safety of SRX246 in irritable subjects with early symptomatic HD when it is given orally at doses up to 160 mg twice daily compared to placebo. .  Approximately 150 HD patients will be screened to enroll 108 subjects at NeuroNEXT sites across the United States.    

Azevan Pharmaceuticals, Inc. is the Sponsor organization for this clinical trial and is conducting the trial through the NeuroNEXT Network under a Cooperative Agreement with the National Institute of Neurological Diseases and Stroke (NINDS).

 

The following institutions are participating in this study:

  • Emory University - Atlanta, GA
  • Masachusetts General Hospital - Boston, MA
  • Northwestern University Feinberg School of Medicine - Chicago, IL
  • The Ohio State University Medical Center - Columbus, OH
  • Oregon Health and Science University - Portland, OR
  • University of Alabama at Birmingham - Birmingham, AL
  • University of California Davis - Davis, CA
  • University of California Los Angeles - Los Angeles, CA
  • University of Cincinnati - Cincinnati, OH
  • University of Colorado Denver - Denver, CO
  • University of Kansas Medical Center - Kansas City, KS
  • University of Miami School of Medicine - Miami, FL
  • University of Pittsburgh - Pittsburgh, PA
  • University of Texas Southwestern Medical Center - Dallas, TX
  • University of Utah - Salt Lake City, UT
  • University of Virginia Charlottesville - Charlottesville, VA
  • Vanderbilt University - Nashville, TN
  • Washington University in St. Louis School of Medicine - St. Louis, MO
  • SUNY Stony Brook University Medical Center - Stony Brook, NY
  • Swedish Health Services/Swedish Medical Center - Seattle, WA
  • New York Presbyterian Hospital/Columbia University Medical Center - New York, NY
  • University of Rochester Medical Center - Rochester, NY