Recruiting

Tesamorelin for Peripheral Nerve Injury Recovery

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Study Aim

This study aims to evaluate the effectiveness of Tesamorelin in improving pinch strength in adults recovering from peripheral nerve injury.

What is being tested

Tesamorelin 2 Milligrams (MG)

Drug
Who is being recruted

Nervous System Diseases+3

+ Neuromuscular Diseases

+ Peripheral Nervous System Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2018
See protocol details

Summary

Principal SponsorJohns Hopkins University
Study ContactSami Tuffaha, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2018

Actual date on which the first participant was enrolled.

This clinical trial is exploring the potential benefits of a drug called tesamorelin for people who have suffered a peripheral nerve injury, specifically to the ulnar nerve, which can affect hand and arm function. Tesamorelin helps increase the production of growth hormone, which has shown promise in animal studies for aiding nerve repair and improving recovery. The main aim is to see if tesamorelin can help improve outcomes for patients, such as better strength and functionality in the affected area. This study is important because nerve injuries can lead to lasting difficulties and finding effective treatments can significantly enhance recovery and quality of life. In this study, 36 participants with repaired ulnar nerve injuries are involved. Half of them will receive tesamorelin, while the other half will not receive any additional treatment, allowing researchers to compare results. All participants will attend 12 monthly follow-up visits for various assessments, including clinical exams, electrical tests of nerve function, and answering questionnaires about their recovery. The effectiveness of the treatment is measured using tests like the "3-point chuck pinch test," which evaluates pinch strength. The study will ensure unbiased results by keeping the evaluators unaware of who received the drug. The trial will last for approximately four years, providing comprehensive data on the potential benefits of tesamorelin.

Official TitleTesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury
NCT03150511
Principal SponsorJohns Hopkins University
Study ContactSami Tuffaha, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeuromuscular DiseasesPeripheral Nervous System DiseasesWounds and InjuriesTrauma, Nervous SystemPeripheral Nerve Injuries

Criteria

1 inclusion criteria required to participate
Ulnar nerve laceration at the wrist, repaired primarily

7 exclusion criteria prevent from participating
Certain cancers (active or in the past)

Uncontrolled diabetes or hypertension

Certain pituitary problems

Oral contraceptives

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Sami Tuffaha

Baltimore, United StatesOpen Sami Tuffaha in Google Maps
Recruiting
One Study Center