Recruiting
Phase 2

Tesamorelin

Sponsor:

Johns Hopkins University

Code:

NCT03150511

Conditions

Peripheral Nerve Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tesamorelin 2 Milligrams (MG)

Study Details

Brief 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.

Conditions

Peripheral Nerve Injuries

Study ID

NCT03150511

Start date

Jun 1, 2018

Status verified date

Nov, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tesamorelin treatment

no intervention: No Drug

Interventions

Tesamorelin 2 Milligrams (MG)

Daily self-administered study drug

Primary outcome measure

  • 3-point chuck pinch test [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sami Tuffaha, MD

410-614-4333stuffah1@jhmi.edu

Locations

Sami Tuffaha

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Ala Elhelali, PhD

667-306-8861aelhela1@jhmi.edu

Principal Investigator:

Sami H Tuffaha, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-12.