Health TrialsbyHealthPanel

Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

ConditionPeripheral Nerve Injuries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ulnar nerve laceration at the wrist, repaired primarily

Disqualifiers

Certain cancers (active or in the past)

Uncontrolled diabetes or hypertension

Certain pituitary problems

Oral contraceptives

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tesamorelin 2 Milligrams (MG)

    Drug

    Daily self-administered study drug

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Tesamorelin treatmentExperimental treatment 1 intervention
Group B: No DrugNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

3-point chuck pinch test

Pinch strength measure as measured by a pinch gauge.

Time frame
12 months

Secondary outcomes

1

Disability of the Arm, Shoulder, and Hand (DASH) score

Questionnaire

Time frame
12 months
2

Michigan Hand Questionnaire score

Questionnaire

Time frame
12 months
3

Amplitude of response

Nerve conduction study measure

Time frame
12 months
4

Latency of response

Nerve conduction study measure

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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