Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Nerve Injuries
• Intervention / Treatment: Drug: Tesamorelin 2 Milligrams (MG)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sami Tuffaha, MD; Phone Number: 410-614-4333; Email: stuffah1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Sami Tuffaha
      • Sub-Investigator: Roberto Salvatori, MD
      • Contact: Ala Elhelali, PhD; Phone Number: 667-306-8861; Email: aelhela1@jhmi.edu
      • Contact: Jaimie Shores, MD
      • Principal Investigator: Sami H Tuffaha, MD
      • Sub-Investigator: Jaimie T Shores, MD
      • Sub-Investigator: Ala Elhelali, PhD
      • Sub-Investigator: Ahmet Hoke, MD
      • Sub-Investigator: Shivani Ahlawat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tesamorelin treatment	Drug: Tesamorelin 2 Milligrams (MG); Daily self-administered study drug; Other Names: Egrifta
No Intervention: No Drug

What is the study measuring?

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
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
Disability of the Arm, Shoulder, and Hand (DASH) score	Questionnaire	12 months
Michigan Hand Questionnaire score	Questionnaire	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Sami Tuffaha, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Estimated): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries; Physiological Effects of Drugs; Growth Substances; tesamorelin
• Other Study ID Numbers: IRB00110936-2; W81XWH-16-C-0188 (Other Grant/Funding Number: Department of Defense); W81XWH-22-1-0257 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No