Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Peripheral Nerve Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150511
• Other study ID #: IRB00110936-2
• Secondary ID: W81XWH-16-C-0188
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: Sami Tuffaha, MD
• Phone: 410-614-4333
• Email: stuffah1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial is to assess the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that treatment with tesamorelin will allow for faster and greater 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 the drug or a placebo (inactive drug). A number of tests for nerve regeneration, muscle function and sensation will be performed every month for a total of 12 months. Outcomes in the patients treated with tesamorelin will be compared to outcomes in patients who received the placebo to determine the effectiveness of tesamorelin as a therapy for nerve injuries.

Description:

This is a multi-institutional, randomized, double-blinded, placebo-controlled 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 the placebo. To avoid bias, the study participants and investigators will be blinded to the treatment group 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, MRI, electrodiagnostic studies and questionnaires. The total duration of the study is expected to be 4 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Wounds and Injuries

Intervention

Drug:
• Tesamorelin 2 Milligrams (MG)
Daily self-administered study drug
• Placebo
Daily self-administered placebo

Locations

Country	Name	City	State
United States	Sami Tuffaha	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-point chuck pinch test	Pinch strength measure as measured by a pinch gauge.	12 months
Secondary	Fractional anisotropy (FA)	MRI diffusion tensor imaging measurement	12 months
Secondary	Apparent diffusion coefficient (ADC)	MRI diffusion tensor imaging measurement	12 months
Secondary	Disability of the Arm, Shoulder, and Hand (DASH) score	Questionnaire	12 months
Secondary	Michigan Hand Questionnaire score	Questionnaire	12 months
Secondary	Amplitude of response	Nerve conduction study measure	12 months
Secondary	Latency of response	Nerve conduction study measure	12 months
Secondary	Velocity of response	Nerve conduction study measure	12 months
Secondary	Modified British Medical Research Council (MBMRC) sensory grading (S0-S4)	Standardized clinical assessment of sensory function using 2-point discrimination and monofilament testing. S0 indicates no recovery and S4 indicates full recovery.	12 months
Secondary	Modified British Medical Research Council (MBMRC) motor grading (M0-M5)	Standardized clinical assessment of motor function. M0 indicates no muscle contraction and M5 indicates active range of motion against strong resistance.	12 months