Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy and Improve Functional Outcomes Following Peripheral Nerve Injury and Repair

Abstract

This study is a randomized, double-blinded, placebo-controlled clinical trial with the primary aim of assessing the efficacy of tesamorelin for peripheral nerve injuries. Patients with ulnar nerve lacerations at the wrist, repaired in a primary fashion, will be eligible for enrolment. Subject recruitment will take place primarily at Johns Hopkins Hospital, Union Memorial Hospital (Curtis National Hand Center), University of Maryland Medical Center/Shock Trauma, and Walter Reed National Military Medical Center. Subject follow up and outcome measurements will take place at Johns Hopkin Hospital. We plan to enroll 36 subjects over 4 years. At the end of the study, if tesamorelin is found to be efficacious, limited off-label use may be justified. Theratechnologies will then pursue a larger Phase 3 clinical trial.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2019
Accession Number
AD1089701

Entities

People

  • Jaimie T. Shores

Organizations

  • Johns Hopkins University

Tags

DTIC Thesaurus Topics

  • Clinical Trials
  • Department Of Defense
  • Electronic Mail
  • Health Services
  • Hospitals
  • Institutional Review Board
  • Maryland
  • Medical Personnel
  • Military Medicine
  • Nervous System
  • Pain
  • Peripheral Nervous System
  • Schools
  • Therapy
  • Ulnar Nerve
  • United States
  • Wounds And Injuries

Fields of Study

  • Medicine

Readers

  • Clinical Trial Research.
  • Trauma Surgery or Emergency Medicine.