Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Официальное название

Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Tesamorelin 2 Milligrams (MG)
  Daily self-administered study drug

Первичные конечные точки

• 3-point chuck pinch test [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Disability of the Arm, Shoulder, and Hand (DASH) score [Срок оценки: 12 months]
• Michigan Hand Questionnaire score [Срок оценки: 12 months]
• Amplitude of response [Срок оценки: 12 months]
• Latency of response [Срок оценки: 12 months]
• Velocity of response [Срок оценки: 12 months]
• Modified British Medical Research Council (MBMRC) sensory grading (S0-S4) [Срок оценки: 12 months]
• Modified British Medical Research Council (MBMRC) motor grading (M0-M5) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Ulnar nerve laceration at the wrist, repaired primarily

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sami Tuffaha — Baltimore

Идентификаторы

NCT: NCT03150511 · IRB00110936-2 · W81XWH-16-C-0188 · W81XWH-22-1-0257

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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