Tesamorelin for Peripheral Nerve Injury

Recruiting at1 trial location

Overseen by Sami Tuffaha, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Oral contraceptives

Disqualifiers: Certain cancers, Diabetes, Hypertension, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests tesamorelin, a drug that increases growth hormone, to help patients with repaired ulnar nerve injuries recover better. The study will compare the recovery of those taking tesamorelin over a year. The goal is to see if tesamorelin improves nerve healing and function. Tesamorelin has been shown to reduce visceral fat and improve lipid profiles in patients with HIV-associated lipodystrophy.

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.

What evidence supports the effectiveness of the drug Tesamorelin for peripheral nerve injury?

While there is no direct evidence for Tesamorelin in treating peripheral nerve injuries, other drugs like zonisamide and FK506 have shown potential in promoting nerve regeneration in preclinical studies. These findings suggest that certain drugs can aid nerve recovery, which might be relevant for exploring Tesamorelin's potential benefits. ^{1 2 3 4 5}

How does the drug Tesamorelin differ from other treatments for peripheral nerve injury?

Tesamorelin is unique because it is a growth hormone-releasing factor analog, which may help in nerve regeneration by promoting the body's natural growth processes, unlike other treatments that focus on direct nerve repair or anti-inflammatory effects. ^{2 3 4 6 7}

Research Team

Sami Tuffaha, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Tesamorelin (Growth Hormone Releasing Factor)

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.

Participant Groups

Group I: Tesamorelin treatment Experimental Treatment 1 Intervention

Group II: No Drug Active Control 1 Intervention

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Systemic and Local FK506 (Tacrolimus) and its Application in Peripheral Nerve Surgery. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Factors influencing nerve regeneration in a trial of timcodar dimesylate. [2012]

4. Netherlands 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. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Promotion of sciatic nerve regeneration in rats by a new neurotrophic pyrimidine derivative MS-430. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Protection of sensory function in diabetic rats by Neotrofin. [2018]

7. India pubmed.ncbi.nlm.nih.gov

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