Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

NCT03150511 — Phase 2, Recruiting, 36 participants, Johns Hopkins University

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

Registry	NCT03150511
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	36 (Estimated)
Sponsor	Johns Hopkins University (Other); collaborators: United States Department of Defense
Conditions	Peripheral Nerve Injuries
Interventions	Tesamorelin 2 Milligrams (MG) (Drug)
Dates	start 2018-06-01, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2017-05-12, last updated 2026-11-09
Locations	1 site in United States

-Summary

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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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Tesamorelin treatment	Experimental	Drug: Tesamorelin 2 Milligrams (MG)
No Drug	No intervention

Tesamorelin 2 Milligrams (MG) (Drug), also known as Egrifta: Daily self-administered study drug

+Outcome measures

Primary outcomes

3-point chuck pinch test [12 months]: Pinch strength measure as measured by a pinch gauge.

Secondary outcomes

Disability of the Arm, Shoulder, and Hand (DASH) score [12 months]: Questionnaire
Michigan Hand Questionnaire score [12 months]: Questionnaire
Amplitude of response [12 months]: Nerve conduction study measure
Latency of response [12 months]: Nerve conduction study measure
Velocity of response [12 months]: Nerve conduction study measure
Modified British Medical Research Council (MBMRC) sensory grading (S0-S4) [12 months]: Standardized clinical assessment of sensory function using 2-point discrimination and monofilament testing. S0 indicates no recovery and S4 indicates full recovery.
Modified British Medical Research Council (MBMRC) motor grading (M0-M5) [12 months]: Standardized clinical assessment of motor function. M0 indicates no muscle contraction and M5 indicates active range of motion against strong resistance.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Sami Tuffaha	Baltimore, Maryland	United States	Recruiting

+Investigators

Sami Tuffaha, MD, Principal investigator, Johns Hopkins University

My Notes

Public

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