DRUG
Tesamorelin 2 Milligrams (MG)
Daily self-administered study drug
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
Status
Recruiting
Phase
Phase 2
Enrollment
36
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 12, 2017
Study start
Jun 1, 2018
Primary completion
Dec 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Nov 12, 2025
Outcomes
What the study measures.
Primary outcomes
3-point chuck pinch test
Time frame · 12 months
Pinch strength measure as measured by a pinch gauge.
Secondary outcomes
Disability of the Arm, Shoulder, and Hand (DASH) score
Time frame · 12 months
Questionnaire
Michigan Hand Questionnaire score
Time frame · 12 months
Questionnaire
Amplitude of response
Time frame · 12 months
Nerve conduction study measure
Latency of response
Time frame · 12 months
Nerve conduction study measure
Velocity of response
Time frame · 12 months
Nerve conduction study measure
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.
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Sami Tuffaha
Baltimore, Maryland, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Tesamorelin.
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Not applicable
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Related PeptideStat pages
Put the record in context.
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