Accession Number:

AD1089701

Title:

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

Descriptive Note:

Technical Report,30 Sep 2018,29 Sep 2019

Corporate Author:

Johns Hopkins University Baltimore United States

Personal Author(s):

Report Date:

2019-10-01

Pagination or Media Count:

35.0

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 CenterShock 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.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE