Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tesamorelin 2 Milligrams (MG).
- Who it may be relevant to
- Registry conditions: Peripheral Nerve Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury
Overview
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.
Interventions
- Drug Tesamorelin 2 Milligrams (MG)
Daily self-administered study drug
Primary outcome measures
- 3-point chuck pinch test [Time frame: 12 months]
Secondary outcome measures (7)
- Disability of the Arm, Shoulder, and Hand (DASH) score [Time frame: 12 months]
- Michigan Hand Questionnaire score [Time frame: 12 months]
- Amplitude of response [Time frame: 12 months]
- Latency of response [Time frame: 12 months]
- Velocity of response [Time frame: 12 months]
- Modified British Medical Research Council (MBMRC) sensory grading (S0-S4) [Time frame: 12 months]
- Modified British Medical Research Council (MBMRC) motor grading (M0-M5) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Sami Tuffaha — Baltimore
Identifiers
NCT: NCT03150511 · IRB00110936-2 · W81XWH-16-C-0188 · W81XWH-22-1-0257