Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

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.

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