Clinical trial NCT03150511: Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
Official title: Tesamorelin Therapy to Enhance Axonal Regeneration, Minimize Muscle Atrophy, and Improve Functional Outcomes Following Peripheral Nerve Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Peripheral Nerve Injuries
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2017-05-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3-point chuck pinch test
timeFrame: 12 months
Secondary outcomes:
measure: Disability of the Arm, Shoulder, and Hand (DASH) score
timeFrame: 12 months
measure: Michigan Hand Questionnaire score
timeFrame: 12 months
measure: Amplitude of response
timeFrame: 12 months
measure: Latency of response
timeFrame: 12 months
measure: Velocity of response
timeFrame: 12 months
measure: Modified British Medical Research Council (MBMRC) sensory grading (S0-S4)
timeFrame: 12 months
measure: Modified British Medical Research Council (MBMRC) motor grading (M0-M5)
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sami Tuffaha
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sami Tuffaha, MD
role: PRINCIPAL_INVESTIGATOR
References: