Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Johns Hopkins University

Status and phase: Enrolling; Phase 2

Conditions: Peripheral Nerve Injuries

Treatments: Drug: Tesamorelin 2 Milligrams (MG)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03150511

W81XWH-22-1-0257 (Other Grant/Funding Number)

W81XWH-16-C-0188 (Other Grant/Funding Number)

IRB00110936-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

Tesamorelin treatment

Experimental group

Treatment:

Drug: Tesamorelin 2 Milligrams (MG)

No Drug

No Intervention group