Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: United States Department of Defense
• Treatments: Growth Hormone-Releasing Hormone; Tesamorelin

Criteria

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