Defining N-Acetyl Cysteine as a Treatment for Inhibiting Prurogenic Stimuli
NCT05287724 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-03-06
Summary
The objective of this double-blinded placebo-controlled cross-over study is to define the role of the over the counter agent, N-acetyl cysteine (NAC), in mitigating the development of pruritus (skin itching). The study is designed to have all subjects treated with a seven-day regimen of both NAC and placebo. NAC will be prescribed at a dose of 1,500 mg twice daily for seven days. Subjects will initially be randomly assigned (1:1) to either the NAC or placebo arm of the study, before crossing over to the opposite arm after completing a minimum of 30-day washout period. The study will encompass a period of approximately 11 weeks (about 2 and a half months).
Conditions
- Pruritus
- Skin Disorder
Interventions
- DRUG
-
N-acetyl cysteine
1,500 mg twice daily for seven days
- DRUG
-
Placebo taken twice daily for seven days
Sponsors & Collaborators
-
Wright State University
lead OTHER
Principal Investigators
-
Craig Rohan, MD · Wright State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-19
- Primary Completion
- 2024-01-04
- Completion
- 2024-01-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Effect of Nicotinamide Riboside and Pterostilbene Supplementation on Muscle Regeneration in Elderly Humans
NCT03754842 ·Status: COMPLETED ·Phase: NA
-
Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects
NCT02088398 ·Status: COMPLETED ·Phase: PHASE1
-
Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy
NCT01537549 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of Rasagiline in Restless Legs Syndrome
NCT01192503 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Bupropion and Restless Legs Syndrome
NCT00621517 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy Confirmation Study of NPC-09
NCT04671472 ·Status: COMPLETED ·Phase: PHASE3
-
A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.
NCT00605930 ·Status: COMPLETED ·Phase: NA
-
XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.
NCT00298623 ·Status: COMPLETED ·Phase: PHASE3
-
Pivotal Study of N-acetyl-L-leucine for CACNA1A
NCT07221292 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
NCT00666965 ·Status: COMPLETED ·Phase: PHASE2
-
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
NCT02720744 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
NCT05978063 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
A Study to Evaluate Vitamin B3 Derivative to Treat Mitochondrial Myopathy
NCT05590468 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Effect of Ropinirole on Spinal Cord Reflexes and Restless Legs Syndrome
NCT00051961 ·Status: COMPLETED
-
ASP8825 - Study in Patients With Restless Legs Syndrome
NCT00530530 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Tolfenamic Acid in Individuals With PSP at 12-Weeks
NCT04253132 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
ALCAR Prophylaxis Study
NCT00225160 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT01281631 ·Status: COMPLETED ·Phase: PHASE2
-
Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
NCT01084551 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Upper or Lower Extremity Muscles Most Affected in Subjects With ALS
NCT03338114 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of Nitrazine in the Treatment of ALS
NCT04950647 ·Status: UNKNOWN ·Phase: PHASE2
-
Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy
NCT00366080 ·Status: TERMINATED ·Phase: PHASE2
-
Phase II Study to Assess Safety, Pharmacokinetics and Efficacy of SL-1002 for Limb Spasticity
NCT05311215 ·Status: UNKNOWN ·Phase: PHASE2
-
A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)
NCT02196324 ·Status: COMPLETED ·Phase: PHASE2
-
Enteral Glutamine in Neurologically-injured Patients
NCT00204971 ·Status: COMPLETED ·Phase: PHASE4