Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 3-point chuck pinch test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulnar nerve laceration at the wrist, repaired primarily
排除标准
- •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
研究组 & 干预措施
Tesamorelin treatment
干预措施: Tesamorelin 2 Milligrams (MG) (Drug)
结局指标
主要结局
3-point chuck pinch test
时间窗: 12 months
Pinch strength measure as measured by a pinch gauge.
次要结局
- Disability of the Arm, Shoulder, and Hand (DASH) score(12 months)
- Michigan Hand Questionnaire score(12 months)
- Amplitude of response(12 months)
- Latency of response(12 months)
- Velocity of response(12 months)
- Modified British Medical Research Council (MBMRC) sensory grading (S0-S4)(12 months)
- Modified British Medical Research Council (MBMRC) motor grading (M0-M5)(12 months)