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

NCT07093944 | Completed Phase 2 DMC

• 2 other identifiers: IR.MUK.REC.1397/348MUKIRAN
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease; N-acetylcysteine

Outcome Measures

Primary Outcomes (2)

• single-photon emission computerized tomography (SPECT) brain imaging

  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.

  one year

• Unified Parkinson's Disease Rating Scale (UPDRS)

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

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

Study Arms (2)

Medication group

EXPERIMENTAL

Receiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg

Drug: N-Acetylcysteine (NAC) Treatment

Placebo group

PLACEBO COMPARATOR

Receiving a placebo with similar appearance, color, odor, and taste like real medication

Drug: Placebo

Interventions

N-Acetylcysteine (NAC) Treatment DRUG

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

Also known as: NAC, Fluimucil effervescent tablet

Medication group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kurdistan University of Medical Sciences: lead

Study Sites (1)

Kurdistan University of Medical Sciences

Sanandaj, Kurdistan Province, Iran

Location

MeSH Terms

Interventions

Acetylcysteine; Therapeutics

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized double-blinded clinical trial study

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: April 9, 2018
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

IR (1)