Parkinson's Disease (PD)Phase 2IRANNACPDNCT07093944
Randomized, Placebo-Controlled Trial of N-acetylcysteine In Parkinson's Disease Patients: A Pilot Study
A Phase 2 study testing N-Acetylcysteine (NAC) Treatment in people with Parkinson's Disease (PD), run by Kurdistan University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- N-Acetylcysteine (NAC) Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIran
- Study dates
- 9 Apr 2018to 22 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient's informed consent No brain surgery in the patient's post medical history
Who cannot join
- having brain surgery within a year before starting the treatment period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of N-acetyl Cysteine as an Adjuvant Therapy on Symptoms and Progression of Parkinson's Disease
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- N-Acetylcysteine (NAC) Treatment, Placebo
- Keywords
- Parkinson's Disease, N-acetylcysteine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetylcysteine (NAC) TreatmentDrug
Also called NAC, Fluimucil effervescent tablet
Parkinson's disease patients receive NAC (1200 mg/day) for one year.
PlaceboDrug
Parkinson's disease patients receive Placebo similar to the real drug, with no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Medication group | Experimental | Receiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg Receives: Drug: N-Acetylcysteine (NAC) Treatment |
| Placebo group | Placebo comparator | Receiving a placebo with similar appearance, color, odor, and taste like real medication Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Unified Parkinson's Disease Rating Scale (UPDRS)
It is a questionnaire to assess the severity and progression of Parkinson's disease.
Measured: one year for each PD patient (at baseline and after one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start9 Apr 2018
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded clinical trial study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurdistan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arman Rahimmi, Kurdistan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093944
- Sponsor's protocol ID
- IR.MUK.REC.1397/348
- Other IDs
- MUKIRAN
- Acronym
- IRANNACPD
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-acetyl Cysteine as an Adjuvant Therapy on Symptoms and Progression of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07093944
- Acronym / sponsor ID
- IRANNACPD / IR.MUK.REC.1397/348
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's Disease, N-acetylcysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kurdistan University of Medical SciencesUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blinded clinical trial study
| Arm | Type | Receives |
|---|---|---|
| Medication group | Experimental | Drug: N-Acetylcysteine (NAC) TreatmentReceiving 1200 mg N-acetylcysteine per day, twice daily, each time 600 mg |
| Placebo group | Placebo comparator | Drug: PlaceboReceiving a placebo with similar appearance, color, odor, and taste like real medication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient's informed consent No brain surgery in the patient's post medical history
Key exclusion criteria (1 listed)
- having brain surgery within a year before starting the treatment period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetylcysteine (NAC) TreatmentAlso: NAC, Fluimucil effervescent tabletParkinson's disease patients receive NAC (1200 mg/day) for one year. | Drug | Medication group |
| PlaceboParkinson's disease patients receive Placebo similar to the real drug, with no active ingredient | Drug | Placebo group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-Acetylcysteine (NAC) Treatment in people with Parkinson's Disease (PD), run by Kurdistan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single-photon emission computerized tomography (SPECT) brain imaging (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.