Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
- Conditions
- Peripheral Nerve Injuries
- Interventions
- Registration Number
- NCT03150511
- Lead Sponsor
- Johns Hopkins University
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- Ulnar nerve laceration at the wrist, repaired primarily
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tesamorelin treatment Tesamorelin 2 Milligrams (MG) -
- Primary Outcome Measures
Name Time Method 3-point chuck pinch test 12 months Pinch strength measure as measured by a pinch gauge.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Sami Tuffaha
🇺🇸Baltimore, Maryland, United States