NAC Attack, A Phase III, Multicenter, Randomized, Parallel, Double Masked, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral N-Acetylcysteine in Patients with Retinitis Pigmentosa
EU CTIS ID: 2022-501438-46-00
What this study is testing
The main objective is to evaluate the efficacy of oral NAC 1800 mg twice a day in maintenance of visual function thereby reducing visual disability in patient with retinitis pigmentosa. The trial will also evaluate the long-term safety and tolerability of NAC 1800 mg twice a day for 45 months.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Ability and willingness to provide informed consent • Age ≥ 18 and ≤65 years at time of signing Informed Consent Form • Ability and willingness to comply with the study protocol and to participate in all study visits and assessments in the investigator’s judgement • For candidates of childbearing potential: willingness to use a method of contraception • Agreement not to take supplements other than vitamin A
You likely can't join if
- General Exclusion Criteria • Active cancer within the past 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with Gleason score ≤ 6 and stable prostate specific antigen for > 12 months • Renal failure requiring renal transplant, hemodialysis, peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis during the study • Liver disease, cystic fibrosis, asthma, or chronic obstructive pulmonary disease (COPD), history of thrombocytopenia not due to a reversible cause or other blood dyscrasia • Uncontrolled blood pressure (defined as systolic > 180 and/or diastolic > 100 mmHg while at rest) at screening. If a patient's initial measurement exceeds these values, a second reading may be taken 30 or more minutes later. If the patient's blood pressure must be controlled by antihypertensive medication, the patient may become eligible if medication is taken continuously for at least 30 days. • History of other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion that oral NAC may be contraindicated or that follow up may be jeopardized • Cerebrovascular accident or myocardial infarction within 6 months of screening • Participation in an investigational study that involves treatment with any drug or device within 6 months of screening • Three relatives already enrolled in study • Pregnant, breast feeding, or intending to become pregnant during the study treatment period. Women of childbearing potential who have not had tubal ligation must have a urine pregnancy test at screening. • Known history of allergy to NAC • Having taken NAC in any form in the past 4 months • Phenylketonuria • Fructose intolerance • Glucose-galactose malabsorption • Sucrase-isomaltase insufficiency • Abnormal laboratory value including the value of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin being greater than 1.5 x the upper limit of normal • Any major abnormal findings on blood chemistry, hematology, and renal function lab tests that in the opinion of the Site Investigator and/or the Study Chair makes the candidate not suitable to participate in the trial • HIV or hepatitis B infection. • Severe angina that requires frequent administration of nitrates
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- United Kingdom
- Switzerland
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; United Kingdom; Switzerland; Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.