What side effects are associated with this type of intervention?

Common treatments for Sjogren's Syndrome include glucocorticoids, immunosuppressants, and dietary supplements like omega-3 fatty acids. Glucocorticoids can cause side effects such as weight gain, osteoporosis, and increased risk of infections. Immunosuppressants like mycophenolate mofetil may lead to gastrointestinal issues, increased susceptibility to infections, and liver toxicity. Omega-3 fatty acid supplements are generally well-tolerated but can cause gastrointestinal discomfort and, at high doses, may increase bleeding risk. Levocarnitine, which enhances fatty acid metabolism, is being studied for its potential benefits, but specific side effects in the context of Sjogren's Syndrome are not well-documented.

What prior FDA approvals exist?

There are no specific FDA-approved drugs that enhance fatty acid metabolism and energy production for the treatment of Sjogren's Syndrome. Treatments for Sjogren's Syndrome generally include immunosuppressive and biologic agents such as hydroxychloroquine, cyclosporine, and rituximab, which target systemic and extraglandular manifestations of the disease. These treatments aim to manage symptoms and reduce inflammation rather than directly enhancing fatty acid metabolism.

What other types of research exist?

Promising novel alternatives to Levocarnitine for Sjogren's Syndrome patients include omega-3 fatty acid supplements, which have shown modest improvements in dry eye symptoms, and investigational therapies such as Lacritin, a tear protein with potential benefits, and Thymosin beta-4, a peptide with wound-healing and anti-inflammatory properties.

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Amino Acid

Levocarnitine for Dry Eye in Sjogren's Syndrome

Phase 2

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

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

Must have

Clinician diagnosis of primary or secondary SjS

Diagnosis of keratoconjunctivitis sicca defined by OSDI ≥ 25 and Schirmer's test ≤ 5mm/5min in at least 1 eye.

Must not have

History of a cornea transplant

Age <18 or >75 at screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks

Awards & highlights

Summary

This trial tests levocarnitine, a supplement that helps transport carnitine into cells, in adults with Sjogren's syndrome who have dry eyes. Sjogren's syndrome causes dryness in the eyes and mouth. Levocarnitine may help by increasing carnitine levels in tears, potentially reducing eye dryness and improving comfort. Levocarnitine is a molecule required in mammalian energy metabolism, facilitating the transport of long-chain fatty acids across the mitochondrial membrane for energy production.

Who is the study for?

Adults with Sjogren's syndrome and dry eye, confirmed by specific tests (OSDI ≥ 25, Schirmer's ≤ 5mm/5min), can join this trial. They must have stable medications for the past month but cannot be using certain eye drops or contact lenses, have had recent ocular surgery, or suffer from severe liver or kidney issues.

What is being tested?

The study is testing Levocarnitine against a placebo to see if it helps with dry eyes in Sjogren's patients. Everyone will get both treatments at different times because it’s a crossover study – meaning participants switch between the drug and placebo.

What are the potential side effects?

Levocarnitine may cause digestive upset, muscle weakness, seizures in those predisposed, fishy body odor, and allergic reactions in sensitive individuals. However, specifics on side effects will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Sjögren's syndrome.

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I have been diagnosed with dry eye syndrome, confirmed by specific eye tests.

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I have been diagnosed with dry eye syndrome.

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I have been diagnosed with Sjögren's syndrome.

Exclusion Criteria

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

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I have had a cornea transplant.

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I am younger than 18 or older than 75.

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You have certain medical conditions such as Hepatitis C, HIV, Sarcoidosis, Amyloidosis, Graft versus host disease, Cicatrizing conjunctivitis, pre-existing lymphoma, or a history of head and neck radiation.

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I am not allergic to the drug being studied or its class.

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I have a current diagnosis of an eye inflammation condition.

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I have a confirmed mitochondrial disorder affecting energy production.

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I can't fully close my eyelids or my eyelashes touch my eyeball.

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I haven't had eye surgery or serious eye injury in the past 6 months and don't plan to during the study.

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I have had a herpes infection in my eye.

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I have had LASIK, PRK, or radial keratectomy eye surgery.

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My kidneys are not working well (creatinine clearance under 30 ml/min).

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I will have a procedure to block my tear ducts during the study.

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I have a history of seizures.

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I have not had a bone marrow transplant or chemotherapy in the last 3 months.

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I am using eye drops for glaucoma or to lower eye pressure.

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I am willing to stop using certain eye drops for the study duration.

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I have permanent eyeliner tattooed on my eyelids.

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I cannot or will not stop using eye drops with L-carnitine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean change in tear inflammatory cytokine milieu

Secondary study objectives

EULAR Sicca Score

EULAR Sjogren's Disease Activity Index

EULAR Sjogren's Syndrome Patient Reported Index

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Experimental: Placebo, LevocarnitineExperimental Treatment2 Interventions

1000 mg of placebo twice per day for six weeks, a two week washout period, 1000 mg of levocarnitine twice per day for 6 weeks

Group II: Experimental: Levocarnitine, PlaceboExperimental Treatment2 Interventions

1000 mg of levocarnitine twice per day for six weeks, a two week washout period, 1000 mg of placebo twice per day for 6 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Levocarnitine

1996

Completed Phase 3

~510

Placebo

1995

Completed Phase 3

~2670

0 / 22Eligibility 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 Sjogren's Syndrome, such as levocarnitine, work by enhancing fatty acid metabolism and energy production, which can reduce fatigue and improve cellular function. Omega-3 and omega-6 fatty acid supplements also play a significant role by providing anti-inflammatory benefits, improving tear production, and maintaining ocular surface health. These mechanisms are crucial for Sjogren's Syndrome patients as they help manage both systemic and localized symptoms, thereby improving overall quality of life.

Carnitine therapy and metabolism in the disorders of propionyl-CoA metabolism studied using 1H-NMR spectroscopy.L-carnitine and rehabilitative respiratory physiokinesitherapy: metabolic and ventilatory response in chronic respiratory insufficiency.Primary carnitine deficiency in two sisters with intractable epilepsy and reversible metabolic cardiomyopathy: Two case reports.