Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Last updated: November 10, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

Tesamorelin 2 Milligrams (MG)

Clinical Study ID

NCT03150511
IRB00110936-2
W81XWH-16-C-0188
W81XWH-22-1-0257
  • Ages > 18
  • All Genders

Study Summary

The aim of this clinical trial is to evaluate the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will result in faster and more substantial 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 tesamorelin treatment or no treatment. Assessments for nerve regeneration, muscle function, and sensation will be conducted every three months for a total of 12 months. Outcomes in patients receiving tesamorelin will be compared to those in the untreated group to determine the effectiveness of tesamorelin as a therapeutic intervention for nerve injuries.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ulnar nerve laceration at the wrist, repaired primarily

Exclusion

Exclusion Criteria:

  • Certain cancers (active or in the past)

  • Uncontrolled diabetes or hypertension

  • Certain pituitary problems

  • Oral contraceptives

  • Pregnancy

  • Drug or alcohol dependence

  • Psychosocial issues that would limit participation and compliance

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 01, 2018
Estimated Completion Date:
December 31, 2027

Study Description

This is a randomized, double-blinded, 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 no treatment. To minimize bias, outcome assessors and the biostatistician analyzing the data will be blinded to the treatment 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, electrodiagnostic studies and questionnaires.

The total duration of the study is expected to be 4 years.

Connect with a study center

  • Sami Tuffaha

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Sami Tuffaha

    Baltimore 4347778, Maryland 4361885 21205
    United States

    Active - Recruiting

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