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Mucolytic Agent

N-acetylcysteine for Lupus (NAC Trial)

Phase 2

Recruiting

Led By Andras Perl, M.D., Ph.D.

Research Sponsored by State University of New York - Upstate Medical University

Eligibility Criteria Checklist

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

Must have

SLE with ≥ 4 of eleven diagnostic criteria approved by the American College of Rheumatology

Age > 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

NAC Trial Summary

This trial is a phase II study to test the safety and efficacy of N-acetyl cysteine (NAC) in treating systemic lupus erythematosus (SLE). SLE is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack specificity and carry significant side-effects. This study will have two groups of 105 subjects each, with one group continuing the tolerated dosage of NAC and the other group switched to placebo capsules. The study will last 13 months with seven study visits per subject. Each subject will donate approximately 100 ml of blood

Who is the study for?

Adults over 18 with active Systemic Lupus Erythematosus (SLE) can join this trial. They should have a certain level of disease activity but not in the kidneys or central nervous system, and be on stable medication doses for SLE. People who are pregnant, breastfeeding, recently in other trials, or have serious health issues like heart failure cannot participate.Check my eligibility

What is being tested?

The study tests N-acetylcysteine (NAC), an antioxidant thought to help with SLE symptoms by adjusting glutathione levels. Participants will first find a tolerable dose over three months before being randomly assigned to continue NAC or switch to placebo for another ten months.See study design

What are the potential side effects?

Potential side effects of N-acetylcysteine may include nausea, vomiting, rash, and headache. However, since it's an antioxidant supplement commonly used for other conditions as well, severe side effects are generally rare.

NAC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with lupus and meet at least 4 of the criteria set by the American College of Rheumatology.

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I am older than 18 years.

NAC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement of disease activity

Therapeutic benefit

Tolerance and safety

Secondary outcome measures

Immunobiological outcomes measurable improved lymphocyte function

NAC Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: NACActive Control1 Intervention

2.4 g - 4.8 g of NAC daily starting after 3 month open label titration period.

Group II: PlaceboPlacebo Group1 Intervention

2.4 g - 4.8 g of placebo per day after 3 month open label titration period.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterOTHER

500 Previous Clinical Trials

164,609 Total Patients Enrolled

Yale UniversityOTHER

1,851 Previous Clinical Trials

2,738,076 Total Patients Enrolled

University of RochesterOTHER

840 Previous Clinical Trials

534,304 Total Patients Enrolled

Media Library

N-acetylcysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00775476 — Phase 2

Lupus Research Study Groups: NAC, Placebo

Lupus Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT00775476 — Phase 2

N-acetylcysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00775476 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main condition that N-acetylcysteine is used as a treatment for?

"N-Acetylcysteine (NAC) is a medication with many potential uses, including the treatment of corneal ulceration and acute rhinitis. It may also be effective in managing corneal diseases."

Answered by AI

What other research has utilized N-acetylcysteine?

"Currently, 40 clinical trials are underway that are investigating the use of N-acetylcysteine (NAC). 7 of those active trials are in Phase 3. While most of the studies for NAC are based in New york City, there are actually 46 different locations across the United States where these trials are taking place."

Answered by AI

How many people total are allowed to enroll in this experiment?

"That is correct. As advertised on clinicaltrials.gov, this research study is still looking for enrollees. The trial was created on March 31st, 2022 and updated most recently on June 15th of the same year. They are currently trying to recruit 290 individuals from a single location."

Answered by AI

Are there any available vacancies for participants in this research?

"Yes, this study is currently looking for individuals to take part in the clinical trial. The first posting was on March 31st, 2022 and there have been subsequent updates on June 15th of the same year."

Answered by AI

Could you please outline the potential risks associated with NAC?

"NAC's safety is estimated to be a 2. In Phase 2 clinical trials, there is some evidence supporting the safety of the medication, but no data to suggest that it is an effective treatment."

Answered by AI