Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Nerve Injuries

Intervention / Treatment
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* Drug: Tesamorelin 2 Milligrams (MG)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tesamorelin treatment<br> | Drug: Tesamorelin 2 Milligrams (MG)<br>* Daily self-administered study drug<br>* Other names: Egrifta;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Daily self-administered placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-point chuck pinch test | Pinch strength measure as measured by a pinch gauge. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional anisotropy (FA) | MRI diffusion tensor imaging measurement | 12 months | 
| Apparent diffusion coefficient (ADC) | MRI diffusion tensor imaging measurement | 12 months | 
| Disability of the Arm, Shoulder, and Hand (DASH) score | Questionnaire | 12 months | 
| Michigan Hand Questionnaire score | Questionnaire | 12 months | 
| Amplitude of response | Nerve conduction study measure | 12 months | 
| Latency of response | Nerve conduction study measure | 12 months | 
| Velocity of response | Nerve conduction study measure | 12 months | 
| Modified British Medical Research Council (MBMRC) sensory grading (S0-S4) | Standardized clinical assessment of sensory function using 2-point discrimination and monofilament testing. S0 indicates no recovery and S4 indicates full recovery. | 12 months | 
| Modified British Medical Research Council (MBMRC) motor grading (M0-M5) | Standardized clinical assessment of motor function. M0 indicates no muscle contraction and M5 indicates active range of motion against strong resistance. | 12 months |