Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

  • STATUS
    Recruiting
  • End date
    Dec 18, 2023
  • participants needed
    36
  • sponsor
    Johns Hopkins University
Updated on 5 March 2022
nerve damage
Accepts healthy volunteers

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.

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.

Details
Condition Peripheral Nerve Injuries
Treatment Placebo, Tesamorelin 2 Milligrams (MG)
Clinical Study IdentifierNCT03150511
SponsorJohns Hopkins University
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ulnar nerve laceration at the wrist, repaired primarily

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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