RecruitingPhase 2NCT03150511

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


Sponsor

Johns Hopkins University

Enrollment

36 participants

Start Date

Jun 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Ulnar nerve laceration at the wrist, repaired primarily

Exclusion Criteria7

  • 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

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Interventions

DRUGTesamorelin 2 Milligrams (MG)

Daily self-administered study drug


Locations(1)

Sami Tuffaha

Baltimore, Maryland, United States

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NCT03150511


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