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NCT Number: NCT07093944

Randomized, Placebo-Controlled Trial of N-acetylcysteine In Parkinson's Disease Patients: A Pilot Study

This is a study on Parkinson's disease patients, referred to Tohid Hospital of Sanandaj City. The patients receive N-acetylcysteine for one year. The efficacy of the Drug is evaluated based on clinical interview, filling Unified Parkinson's Disease Rating Scale (UPDRS) questionnaire, and single-photon emission computerized tomography (SPECT) brain imaging. The only person who has not been blinded for the study is the supplier of the drug and placebo.

Inclusion criteria: Patient's informed consent Exclusion criteria: Having brain surgery within a year before the initiation of the intervention.

Medication group: receiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg.

placebo group: receiving a placebo with similar appearance, color, odor, and taste like real medication.

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Key information

Conditions

Parkinson's Disease (PD)

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kurdistan University of Medical Sciences

Sanandaj, Kurdistan Province, Iran

About this study

This is a randomized double-blinded clinical trial. Randomization method is based on making blocks with size of 4 people, to divide participants into two groups: intervention group (A) and control group (B). So that, we divide all participants to four-sample blocks, and we allocate the block's samples equally between the two groups (e.g. ABAB). This pattern is the same in all blocks. Participants, clinical caregivers, outcome evaluators and data analyzers are not aware whether the therapeutic regimens include the drug or placebo. only the main researcher and pharmacist are aware of nature of therapeutic regimen based on codes given to the drug and placebo packages, earlier.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient's informed consent No brain surgery in the patient's post medical history

Exclusion criteria

  • having brain surgery within a year before starting the treatment period

Treatment and study plan

N-Acetylcysteine (NAC) Treatment

Drug

Parkinson's disease patients receive NAC (1200 mg/day) for one year.

Other names: NAC, Fluimucil effervescent tablet

Placebo

Drug

Parkinson's disease patients receive Placebo similar to the real drug, with no active ingredient

Primary outcomes

  1. single-photon emission computerized tomography (SPECT) brain imaging

    Time frame: one year

    Also known as TRODAT scan or DaTscan, is a nuclear medicine imaging procedure that helps diagnose and evaluate Parkinson's disease by assessing the function of dopamine transporters in the brain. It specifically visualizes the dopaminergic system, which is affected in Parkinson's disease.

  2. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: one year for each PD patient (at baseline and after one year)

    It is a questionnaire to assess the severity and progression of Parkinson's disease.

Sponsors and collaborators

Lead sponsor

Kurdistan University of Medical Sciences

Other

Registry information

Official study title

Effect of N-acetyl Cysteine as an Adjuvant Therapy on Symptoms and Progression of Parkinson's Disease

Acronym: IRANNACPD

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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