Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

What Was Tested

The trial (phase 2) is built around Tesamorelin.

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.

It had two arms (groups): Tesamorelin treatment (experimental) and No Drug (no intervention).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

36 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ulnar nerve laceration at the wrist, repaired primarily.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: certain cancers (active or in the past); uncontrolled diabetes or hypertension; certain pituitary problems.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Tesamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Tesamorelin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-06-01 with completion listed for 2027-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 3-point chuck pinch test (time frame: 12 months).

It also tracked 7 secondary outcomes, for example Disability of the Arm, Shoulder, and Hand (DASH) score, Michigan Hand Questionnaire score, Amplitude of response, Latency of response, Velocity of response and Modified British Medical Research Council (MBMRC) sensory grading (S0-S4).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin in 36 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tesamorelin compound page, all human trials.