Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Status Recruiting

Clinical Trial Summary

The aim of this clinical trial is to assess the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will allow for faster and greater recovery of motor and sensory function following surgical repair of injured peripheral nerves. Patients with upper extremity nerve injuries will be randomly assigned to receive either the drug or a placebo (inactive drug). A number of tests for nerve regeneration, muscle function and sensation will be performed every month for a total of 12 months. Outcomes in the patients treated with tesamorelin will be compared to outcomes in patients who received the placebo to determine the effectiveness of tesamorelin as a therapy for nerve injuries.

Clinical Trial Description

This is a multi-institutional, randomized, double-blinded, placebo-controlled clinical trial assessing the efficacy of tesamorelin as a therapy to improve functional recovery following peripheral nerve injury. Tesamorelin is a drug that stimulates increased production of growth hormone, and growth hormone has been shown to improve nerve regeneration and functional recovery in animal studies. A total of 36 participants with repaired ulnar nerve lacerations will be enrolled, of which 18 will be randomly assigned to receive the study drug and 18 will receive the placebo. To avoid bias, the study participants and investigators will be blinded to the treatment group assignments. Following enrollment, each participant will have 12 monthly follow-up visits during which participants will undergo testing to assess recovery. Outcome assessments will include clinical exams, MRI, electrodiagnostic studies and questionnaires. The total duration of the study is expected to be 4 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03150511
Study type	Interventional
Source	Johns Hopkins University
Contact	Sami Tuffaha, MD
Phone	410-614-4333
Email	stuffah1@jhmi.edu
Status	Recruiting
Phase	Phase 2
Start date	June 1, 2018
Completion date	December 2025

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See also
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