Trial · Interventional
RecruitingPhase 2Registry dataTesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
Overview
- Status
- Recruiting
- Phase
- Phase 2
- Enrollment
- 36 participants (estimated)
- Sponsor
- Johns Hopkins University · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 1 Jun 2018
- Primary completion
- Dec 2027 (estimated)
- Completion
- Dec 2027 (estimated)
- First posted
- 12 May 2017
- Last update posted
- 12 Nov 2025
- Conditions
- Peripheral Nerve Injuries
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
NCT031505111 Jun 2018 to est. Dec 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Tesamorelin 2 Milligrams (MG)Drug
Arms2
Experimental
Tesamorelin treatment
No intervention
No Drug
Primary outcomes1
Outcomes the sponsor listed as primary.
3-point chuck pinch test
Time frame · 12 months
Registry description
Pinch strength measure as measured by a pinch gauge.
Secondary outcomes(7)
Disability of the Arm, Shoulder, and Hand (DASH) score
Time frame · 12 months
Registry description
Questionnaire
Michigan Hand Questionnaire score
Time frame · 12 months
Registry description
Questionnaire
Amplitude of response
Time frame · 12 months
Registry description
Nerve conduction study measure
Latency of response
Time frame · 12 months
Registry description
Nerve conduction study measure
Velocity of response
Time frame · 12 months
Registry description
Nerve conduction study measure
Modified British Medical Research Council (MBMRC) sensory grading (S0-S4)
Time frame · 12 months
Registry description
Standardized clinical assessment of sensory function using 2-point discrimination and monofilament testing. S0 indicates no recovery and S4 indicates full recovery.
Modified British Medical Research Council (MBMRC) motor grading (M0-M5)
Time frame · 12 months
Registry description
Standardized clinical assessment of motor function. M0 indicates no muscle contraction and M5 indicates active range of motion against strong resistance.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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