What side effects are associated with this type of intervention?

Common treatments for peripheral nerve injury include medications like pregabalin and duloxetine, physical therapy, and investigational treatments such as growth hormone-releasing factor analogs like Tesamorelin. Known side effects of these treatments can vary. For pregabalin, side effects may include dizziness, drowsiness, and peripheral edema. Duloxetine can cause nausea, dry mouth, and fatigue. Growth hormone-releasing factor analogs, such as Tesamorelin, may lead to side effects like injection site reactions, joint pain, and increased blood sugar levels. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for peripheral nerve injury similar to Tesamorelin (a Growth Hormone-Releasing Factor Analog) in the provided context. However, the context does discuss various investigational treatments and therapies for nerve injuries, such as tesamorelin, which is currently being studied for its potential to improve motor and sensory function following surgical repair of peripheral nerves. Broadly, treatments for peripheral nerve injuries often focus on surgical repair, physical therapy, and sometimes investigational drugs aimed at enhancing nerve regeneration and functional recovery.

What other types of research exist?

Promising alternatives to Tesamorelin for peripheral nerve injury include TA-0910, a TRH analog that has shown significant neuroprotective effects in axotomy-induced neuronal death, and darbepoetin, which has demonstrated accelerated recovery of nerve function in facial nerve injury models.

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Growth Hormone Releasing Factor

Tesamorelin for Peripheral Nerve Injury

Phase 2

Recruiting

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ulnar nerve laceration at the wrist, repaired primarily

Be older than 18 years old

Must not have

History of certain cancers (active or in the past)

Uncontrolled diabetes or hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not detailed here, common ones associated with tesamorelin may include joint pain, skin reactions at the injection site, muscle pain, swelling in hands or feet and less commonly hypersensitivity reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of cancer.

Select...

My diabetes or blood pressure is not well-controlled.

Select...

I am currently using oral contraceptives.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

3-point chuck pinch test

Secondary study objectives

Amplitude of response

Apparent diffusion coefficient (ADC)

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

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tesamorelin treatmentExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for peripheral nerve injury include physical therapy, surgical repair, and pharmacological agents like growth hormone-releasing factor analogs. Tesamorelin, for example, promotes nerve regeneration by stimulating the release of growth hormone, which in turn enhances the repair and regrowth of nerve tissues. This is crucial for patients as it can lead to faster and more complete recovery of motor and sensory functions, improving overall quality of life and reducing long-term disability.

Combinatorial treatments enhance recovery following facial nerve crush.