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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
Study Summary
This trial will test whether levocarnitine can relieve dry eye symptoms in adults with Sjogren's syndrome.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I have been diagnosed with Sjögren's syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in tear inflammatory cytokine milieu
Secondary outcome measures
EULAR Sicca Score
EULAR Sjogren's Disease Activity Index
EULAR Sjogren's Syndrome Patient Reported Index
+7 moreTrial 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
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,177 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious eye infection, like severe blepharitis, in the past 3 months.I have had a cornea transplant.I am younger than 18 or older than 75.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.I am not allergic to the drug being studied or its class.I have a current diagnosis of an eye inflammation condition.I have a confirmed mitochondrial disorder affecting energy production.I can't fully close my eyelids or my eyelashes touch my eyeball.I haven't had eye surgery or serious eye injury in the past 6 months and don't plan to during the study.I have had a herpes infection in my eye.I haven't taken levocarnitine or L-carnitine supplements in the last 2 months.I have been diagnosed with Sjögren's syndrome.You have a medical or mental health condition that the researcher believes could put you at too much risk or make the study results less reliable.I have been diagnosed with dry eye syndrome, confirmed by specific eye tests.I have had LASIK, PRK, or radial keratectomy eye surgery.I have been diagnosed with dry eye syndrome.My kidneys are not working well (creatinine clearance under 30 ml/min).I will have a procedure to block my tear ducts during the study.I am willing to not wear contact lenses for the study duration.I have a history of seizures.I have a condition that affects the health of my eye's surface.I have not had a bone marrow transplant or chemotherapy in the last 3 months.I am using eye drops for glaucoma or to lower eye pressure.I am willing to stop taking oral supplements for dry eye, like fish oil, for the study duration.I have been diagnosed with Sjögren's syndrome.I am willing to stop using certain eye drops for the study duration.My medications have not changed in the last 4 weeks.I have permanent eyeliner tattooed on my eyelids.I cannot or will not stop using eye drops with L-carnitine.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Levocarnitine, Placebo
- Group 2: Experimental: Placebo, Levocarnitine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sjogren's Syndrome Patient Testimony for trial: Trial Name: NCT03953703 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical experiment include participants aged seventy and above?
"The present medical trial is recruiting patients aged from 18 to 75. The same research has identified 379 studies for minors and 1059 for seniors."
Answered by AI
Are there any available openings remaining in this clinical trial?
"As per the clinicaltrials.gov listing, this trial is currently enrolling participants. This research project was posted on November 17th 2021 and the latest update occurred January 31st 2022."
Answered by AI
What is the current number of subjects participating in this experiment?
"Absolutely. According to the clinicaltrials.gov data, this research is currently recruiting participants after it was first posted on November 17th 2021 and last revised on January 31st 2022. The trial requires 15 volunteers from 1 centre for completion."
Answered by AI
Do I meet the qualifications to participate in this medical experiment?
"This clinical trial wants to recruit 15 patients aged 18-75 that currently experience sicca syndrome. Additionally, suitable candidates must have been prescribed a stable medication regimen for the past 4 weeks and test positive for anti-SSA antibodies."
Answered by AI
To what extent has Levocarnitine been investigated in other medical trials?
"Currently, 8 clinical trials involving Levocarnitine are ongoing. One of these investigations is in its final phase 3 stage. Primarily based out of Nashville, Tennessee; 18 medical centres across the country have joined forces to further research this treatment option."
Answered by AI
What conditions is Levocarnitine commonly employed to address?
"Levocarnitine is a therapeutically-administered compound that can help with secondary carnitine deficiency, congenital carnitine deficiency, and end stage renal disease (ESRD)."
Answered by AI
Is Levocarnitine recognized by the Federal Drug Administration?
"With Levocarnitine, there is evidence that it may be safe but no definitive proof of its efficacy. This has been rated a 2 on our internal scale at Power."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
Tennessee
How old are they?
18 - 65
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been diagnosed with Sjogren’s syndrome for several years now. There has been other major issues that I now have due to this disease. This disease has put me on disability and ruined my life. Everyday I try to figure out a way to treat all of my new bothersome symptoms. I try has put me in Great Depression. Please, please, please let me be apart of this study. All I have done is try to figure out a way to return back to a somewhat normal life. This would mean EVERYTHING to me to be a part of this trial. I pray you will accept me as it would mean more than the world to me. Thank you for your consideration.
PatientReceived 2+ prior treatments
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