Actively Recruiting
Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury
Led by Johns Hopkins University · Updated on 2025-11-12
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of tesamorelin as a possible treatment to improve recovery after peripheral nerve injuries, specifically focusing on patients with ulnar nerve lacerations at the wrist that have been surgically repaired. The study aims to determine whether tesamorelin can speed up and enhance the return of motor and sensory functions after such injuries. This is a randomized, double-blinded clinical trial designed to evaluate the effects of tesamorelin compared to no treatment in this patient group. Participants will be randomly assigned to one of two groups: one receiving daily self-administered tesamorelin at a dose of 2 milligrams, and the other receiving no drug treatment. There will be 36 participants in total, with 18 individuals in each group. The study will last for about four years, including 12 monthly follow-up visits after enrollment. During these visits, assessments will be conducted to measure nerve regeneration, muscle function, and sensation using clinical exams, electrodiagnostic studies, and questionnaires. Throughout the 12-month follow-up period, investigators will regularly evaluate recovery using tests such as the 3-point chuck pinch test and various questionnaires including the Disability of the Arm, Shoulder, and Hand (DASH) score and the Michigan Hand Questionnaire. Additional measurements will include response amplitude, latency, velocity, and sensory and motor grading scales. The study will monitor participant progress closely to compare outcomes between those receiving tesamorelin and those not receiving treatment, aiming to understand tesamorelin's potential benefits in nerve injury recovery.
CONDITIONS
Brief Title
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ulnar nerve laceration at the wrist, repaired primarily
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive daily self-administered tesamorelin or no treatment over the course of the study.
Monthly visits for 12 months
Duration - 12 months concurrent with treatment
Participants have monthly follow-up visits during which recovery is assessed through clinical exams, electrodiagnostic studies, and questionnaires.
Monthly visits for 12 months
Trial Site Locations
Total: 1 location
1
Sami Tuffaha
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
S
Sami Tuffaha, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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