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NCT Number: NCT03150511

Tesamorelin to Improve Functional Outcomes After 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.

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Key information

Conditions

Peripheral Nerve Injuries Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sami Tuffaha

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Ahmet Hoke, MD

SUB_INVESTIGATOR

Ala Elhelali, PhD

CONTACT

[email protected]

667-306-8861

Ala Elhelali, PhD

SUB_INVESTIGATOR

Jaimie Shores, MD

CONTACT

Jaimie T Shores, MD

SUB_INVESTIGATOR

Roberto Salvatori, MD

SUB_INVESTIGATOR

Sami H Tuffaha, MD

PRINCIPAL_INVESTIGATOR

Shivani Ahlawat, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tesamorelin 2 Milligrams (MG)

Drug

Daily self-administered study drug

Other names: Egrifta

Primary outcomes

  1. 3-point chuck pinch test

    Time frame: 12 months

    Pinch strength measure as measured by a pinch gauge.

Secondary outcomes

  1. Disability of the Arm, Shoulder, and Hand (DASH) score

    Time frame: 12 months

    Questionnaire

  2. Michigan Hand Questionnaire score

    Time frame: 12 months

    Questionnaire

  3. Amplitude of response

    Time frame: 12 months

    Nerve conduction study measure

  4. Latency of response

    Time frame: 12 months

    Nerve conduction study measure

  5. Velocity of response

    Time frame: 12 months

    Nerve conduction study measure

  6. Modified British Medical Research Council (MBMRC) sensory grading (S0-S4)

    Time frame: 12 months

    Standardized clinical assessment of sensory function using 2-point discrimination and monofilament testing. S0 indicates no recovery and S4 indicates full recovery.

  7. Modified British Medical Research Council (MBMRC) motor grading (M0-M5)

    Time frame: 12 months

    Standardized clinical assessment of motor function. M0 indicates no muscle contraction and M5 indicates active range of motion against strong resistance.

Study contacts

Contact information is provided by the study sponsor or research team.

Sami Tuffaha, MD

CONTACT

[email protected]

410-614-4333

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
May 12, 2017
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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