• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Remedy initiates phase IIa study of CIRARA

Remedy initiates phase IIa study of CIRARA

August 19, 2015
CenterWatch Staff

Remedy Pharmaceuticals, a company focused on the development and commercialization of CIRARA, a breakthrough drug for treating acute central nervous system conditions, has initiated a prospective, multicenter, open-label pilot study of CIRARA in patients with acute traumatic cervical spinal cord injuries.

Up to five Level I trauma centers will be involved in the trial, including University of Ohio Wexner Medical Center as Principal Site. The study’s principal investigator is H. Francis Farhadi, M.D., Ph.D., clinical assistant professor, Department of Neurological Surgery and director, Spinal Surgery Fellowship Program at The Ohio State University.

According to the World Health Organization, annually there are somewhere between 133,000 and 226,000 cases of spinal cord injury worldwide. There are about 12,000 new cases of spinal cord injury each year in the United States. Presently, more than 250,000 Americans are living with a spinal cord injury.

The study will enroll and treat up to a maximum of 10 patients who will be matched in a 1:3 ratio with historical controls. Patients with cervical (C4-C8) level complete or incomplete injuries who are aged 18 to 70 years old will be eligible for inclusion in the study.

The data obtained from this pilot study should inform the design of further multicenter phase II/III clinical studies evaluating the efficacy of CIRARA in improving functional outcomes following SCI.

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing