AC 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

Phase 1

Recruiting

• Conditions: Retinitis Pigmentosa; MedDRA version: 20.0Level: PTClassification code: 10038914Term: Retinitis pigmentosa Class: 100000004850; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: CTIS2022-501438-46-00
• Lead Sponsor: Johns Hopkins University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 498

Inclusion Criteria

•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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified