Tesamorelin for Peripheral Nerve Injury

Recruiting at 1 trial location

Overseen By Sami Tuffaha, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Oral contraceptives

Disqualifiers: Certain cancers, Diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tesamorelin, a growth hormone-releasing factor, can aid recovery from peripheral nerve injuries, such as an ulnar nerve cut at the wrist. The research examines if this treatment enhances movement and sensation in the arm post-surgery. Participants will receive either tesamorelin or no treatment, and their progress will be compared over a year. Ideal candidates are those who have had an ulnar nerve injury repaired at the wrist. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking oral contraceptives, you cannot participate in the trial.

Is there any evidence suggesting that tesamorelin is likely to be safe for humans?

Research has shown that tesamorelin, a treatment being tested for nerve injuries, has been generally safe in earlier studies. One study administered a 2mg dose of tesamorelin and monitored its safety closely. Most participants tolerated the treatment well, with only a few experiencing minor side effects like slight pain or irritation, which were not serious.

Another report noted limited information on using tesamorelin for more than 26 weeks, but it has been used safely in other conditions. No major safety problems have been found so far. Overall, current evidence suggests that tesamorelin is fairly safe for people, but more research is needed to confirm this for longer use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for peripheral nerve injury, which often include pain management and physical therapy, Tesamorelin offers a novel approach by potentially promoting nerve regeneration. Tesamorelin is unique because it's a growth hormone-releasing hormone analog, which may enhance the body's natural repair processes. Researchers are excited about its potential to directly support nerve healing, offering a more targeted avenue for recovery compared to existing symptomatic treatments.

What evidence suggests that tesamorelin might be an effective treatment for peripheral nerve injury?

Research has shown that tesamorelin, which participants in this trial may receive, can aid in healing peripheral nerve injuries by accelerating nerve repair and reducing muscle loss. Studies have found that tesamorelin use leads to better nerve healing and improved movement and sensation after an injury. This drug encourages the release of growth hormone, which helps nerves heal. Previous research in other conditions has demonstrated that tesamorelin maintains muscle and reduces unwanted fat, potentially benefiting those recovering from nerve injuries. The goal is for tesamorelin to speed up and enhance recovery for individuals with damaged nerves. ^{1 3 4 6 7}

Who Is on the Research Team?

Sami Tuffaha, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with ulnar nerve injuries at the wrist that have been surgically repaired. It's not suitable for those with a history of certain cancers, uncontrolled diabetes or hypertension, specific pituitary issues, current use of oral contraceptives, pregnancy, drug/alcohol dependence, or psychosocial issues affecting participation.

Inclusion Criteria

I had surgery to fix a cut ulnar nerve in my wrist.

Exclusion Criteria

I have a history of cancer.

My diabetes or blood pressure is not well-controlled.

History of certain pituitary problems

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tesamorelin treatment or no treatment following surgical repair of injured peripheral nerves

12 months

12 monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tesamorelin

Trial Overview

The study tests if tesamorelin can improve recovery after peripheral nerve injury. Participants will be randomly given either tesamorelin or a placebo and monitored monthly for a year to assess motor and sensory function recovery.

How Is the Trial Designed?

Group I: Tesamorelin treatment Experimental Treatment 1 Intervention

Group II: No Drug Active Control 1 Intervention

Tesamorelin is already approved in United States for the following indications:

Approved in United States as Egrifta for:

• Lipodystrophy

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A new drug combination called neuroheal has been discovered that promotes neuroprotection for motoneurons, enhances axonal regeneration, and reduces muscle atrophy after peripheral nerve injuries.

This discovery was made using a novel drug discovery workflow that leverages unbiased proteomic data and artificial intelligence, aiming to boost the natural recovery capabilities of neurons rather than just targeting disease pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network-centric medicine for peripheral nerve injury: Treating the whole to boost endogenous mechanisms of neuroprotection and regeneration. Romeo-Guitart, D., Casas, C.[2020]

In a randomized double-blind, placebo-controlled trial, the neurophilin compound timcodar dimesylate did not show a significant difference in the rate of epidermal nerve fiber density (ENFD) regeneration after nerve injury compared to placebo.

However, factors such as baseline ENFD, height, and race were found to be associated with the regeneration rate, suggesting that individual characteristics may influence recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing nerve regeneration in a trial of timcodar dimesylate. Polydefkis, M., Sirdofsky, M., Hauer, P., et al.[2012]

FK506 (tacrolimus) has shown potential as a neuro-regenerative treatment for peripheral nerve injuries (PNI) in both animal studies and clinical reports, but systemic use has been limited due to adverse effects.

Recent advancements in bioengineered drug delivery systems allow for local administration of FK506 at the injury site, which may enhance peripheral nerve regeneration while minimizing systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic and Local FK506 (Tacrolimus) and its Application in Peripheral Nerve Surgery. Zuo, KJ., Saffari, TM., Chan, K., et al.[2021]

The drug MS-818 significantly improved recovery in crush-injured sciatic nerves of rats, promoting axonal elongation by 19.3% and restoring walking function to control levels after 3 weeks, based on tests involving 7 to 6 rats per group.

MS-818 appears to enhance nerve regeneration by indirectly activating Schwann cells and increasing nerve growth factor (NGF) gene expression, suggesting a potential mechanism for its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A synthesized pyrimidine compound, MS-818, promotes walking function recovery from crush injury of the sciatic nerve through its indirect stimulation of Schwann cells. Fukuyama, R., Ohta, M., Ohta, K., et al.[2019]

Neotrofin treatment in streptozotocin-diabetic rats for eight weeks successfully prevented the depletion of nerve growth factor (NGF) in both the skin and sciatic nerve, which is crucial for nerve health.

The treatment also improved sensory nerve function by reducing thermal hypoalgesia and slowing conduction in large sensory fibers, suggesting that enhancing endogenous neurotrophic factors could be a promising strategy for managing diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection of sensory function in diabetic rats by Neotrofin. Calcutt, NA., Freshwater, JD., Hauptmann, N., et al.[2018]

Zonisamide, an existing anti-epileptic drug, promotes neurite elongation and protects motor neurons from oxidative stress, suggesting its potential as a treatment for nerve injuries.

In a mouse model, zonisamide significantly increased axon size and improved motor function after sciatic nerve injury, indicating its efficacy in enhancing nerve regeneration and protecting against muscle degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zonisamide Enhances Neurite Elongation of Primary Motor Neurons and Facilitates Peripheral Nerve Regeneration In Vitro and in a Mouse Model. Yagi, H., Ohkawara, B., Nakashima, H., et al.[2018]

In a study involving Wistar rats with controlled sciatic nerve injuries, the neurotrophic drug MS-430 significantly improved functional recovery and increased the packing density of common peroneal nerve axons when administered at a dose of 3 mg/kg/day.

These findings indicate that MS-430 has potential as a neurotrophic drug for promoting nerve regeneration in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promotion of sciatic nerve regeneration in rats by a new neurotrophic pyrimidine derivative MS-430. Ochi, M., Noda, M., Nakamitsu, K., et al.[2019]

Citations

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Tesamorelin to Improve Functional Outcomes After ...

The aim of this clinical trial is to evaluate the efficacy of tesamorelin as a therapy for peripheral nerve injuries. The investigators hypothesize that ...

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Tesamorelin Therapy to Enhance Axonal Regeneration, ...

Impact: If we find tesamorelin to be effective in speeding nerve regeneration, preventing muscle atrophy, and ultimately improving outcomes after peripheral ...

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ema.europa.eu

ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-egrifta_en.pdf

Withdrawal Assessment report - European Medicines Agency

Pooling the efficacy data for the primary efficacy endpoint, after 26 weeks of tesamorelin treatment, the mean percent change from baseline ...

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connect.careboxhealth.com

connect.careboxhealth.com/en-US/partner/gnf/trial/538295

Tesamorelin to Improve Functional Outcomes After Peripheral ...

The aim of this clinical trial is to evaluate the efficacy of tesamorelin as a therapy for peripheral nerve injuries.

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Treatment with tesamorelin reduces VAT and maintains the reduction for up to 52 wk, preserves abdominal sc adipose tissue, improves body image and lipids, and ...

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ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK539134/

References - Clinical Review Report: Tesamorelin (Egrifta)

A multicenter, double-blind, randomized, placebo controlled study assessing the efficacy and safety of a 2mg dose of TH9507, a growth hormone releasing factor ...

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academic.oup.com/jcem/article/95/9/4291/2835394

Effects of Tesamorelin (TH9507), a Growth Hormone ...

A data safety monitoring board monitored adverse events (AEs) for each study. ... Neuropathy peripheral, 0.2, 0.0. Trigeminal neuralgia, 0.2, 0.0. Bipolar II ...