Idiopathic Parkinson DiseasePRIPSNCT07163156
Prolactin, Inflammation, and Parkinson's Severity
An observational study of Idiopathic Parkinson Disease and Prolactin, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional observational study aims to evaluate the relationship between serum prolactin levels, peripheral inflammatory markers (NLR, PLR, SII, CRP), and disease severity in patients with Parkinson's disease (PD). A total of at least 300 patients diagnosed with idiopathic PD will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Parkinson Disease, Prolactin, Prolactin Levels
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Aug 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of at least 300 adult patients (≥18 years) diagnosed with idiopathic Parkinson's disease who are followed at the Neurology Department of Çanakkale Onsekiz Mart University. Both male and postmenopausal female patients will be included. Participants must be clinically stable and able to undergo neurological evaluation, serum and salivary prolactin testing, and routine laboratory investigations. Patients with atypical or secondary parkinsonism, endocrine disorders affecting prolactin levels, active infection, chronic inflammatory disease, or malignancy will be excluded.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of idiopathic Parkinson's disease confirmed by a neurologist
- Both male and postmenopausal female patients
- Patients able to provide informed consent
- Clinically stable enough to undergo blood and saliva sampling, as well as neurological assessment
Who cannot join
- Premenopausal female patients
- Patients with secondary or atypical parkinsonism (e.g., drug-induced, vascular, atypical parkinsonian syndromes)
- Known endocrine disorders affecting prolactin levels (e.g., prolactinoma, pituitary adenoma, hypothyroidism)
- Use of medications known to alter prolactin secretion (e.g., antipsychotics, dopamine antagonists, estrogen therapy)
- History of other neurodegenerative diseases (e.g., Alzheimer's, Huntington's)
- Presence of active infection, chronic inflammatory disease, or malignancy
- Severe renal, hepatic, or cardiac failure
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart University
Çanakkale, Merkez, 17020
About this study
Official title: The Relationship of Prolactin and Inflammatory Markers With Parkinson's Disease Severity: Clinical and Biochemical Evaluation
This cross-sectional observational study aims to evaluate the relationship between serum prolactin levels, peripheral inflammatory markers (NLR, PLR, SII, CRP), and disease severity in patients with Parkinson's disease (PD). A total of at least 300 patients diagnosed with idiopathic PD will be included. Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) and the Modified Hoehn-Yahr staging system. Serum and salivary prolactin levels will be measured using ELISA, while inflammatory markers will be calculated from routine blood tests. The study seeks to clarify whether prolactin and systemic inflammation indicators may serve as non-invasive biomarkers for disease progression and prognosis in PD, with particular emphasis on postmenopausal women.
- Medical subject headings
- Parkinson Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Parkinson's Disease Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic inflammatory markers
NLR, PLR, SII, CRP
Measured: 1 year later
Prolactin Level
Serum prolactine levels
Measured: 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start14 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hüseyin Avni Eroğlu, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163156
- Sponsor's protocol ID
- COMU-FNN-1
- Other IDs
- NOT YET
- Acronym
- PRIPS
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Prolactin and Inflammatory Markers With Parkinson's Disease Severity: Clinical and Biochemical Evaluation
- ClinicalTrials.gov ID
- NCT07163156
- Acronym / sponsor ID
- PRIPS / COMU-FNN-1
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Sep 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 cross-sectional observational study aims to evaluate the relationship between serum prolactin levels, peripheral inflammatory markers (NLR, PLR, SII, CRP), and disease severity in patients with Parkinson's disease (PD). A total of at least 300 patients diagnosed with idiopathic PD will be included. Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) and the Modified Hoehn-Yahr staging system. Serum and salivary prolactin levels will be measured using ELISA, while inflammatory markers will be calculated from routine blood tests. The study seeks to clarify whether prolactin and systemic inflammation indicators may serve as non-invasive biomarkers for disease progression and prognosis in PD, with particular emphasis on postmenopausal women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Parkinson's Disease Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of at least 300 adult patients (≥18 years) diagnosed with idiopathic Parkinson's disease who are followed at the Neurology Department of Çanakkale Onsekiz Mart University. Both male and postmenopausal female patients will be included. Participants must be clinically stable and able to undergo neurological evaluation, serum and salivary prolactin testing, and routine laboratory investigations. Patients with atypical or secondary parkinsonism, endocrine disorders affecting prolactin levels, active infection, chronic inflammatory disease, or malignancy will be excluded.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosis of idiopathic Parkinson's disease confirmed by a neurologist
- Both male and postmenopausal female patients
- Patients able to provide informed consent
- Clinically stable enough to undergo blood and saliva sampling, as well as neurological assessment
Key exclusion criteria (8 listed)
- Premenopausal female patients
- Patients with secondary or atypical parkinsonism (e.g., drug-induced, vascular, atypical parkinsonian syndromes)
- Known endocrine disorders affecting prolactin levels (e.g., prolactinoma, pituitary adenoma, hypothyroidism)
- Use of medications known to alter prolactin secretion (e.g., antipsychotics, dopamine antagonists, estrogen therapy)
- History of other neurodegenerative diseases (e.g., Alzheimer's, Huntington's)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systemic inflammatory markers
Time frame: 1 year later
NLR, PLR, SII, CRP
Prolactin Level
Time frame: 1 year later
Serum prolactine levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
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?
An observational study of Idiopathic Parkinson Disease and Prolactin, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 9 Sep 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Systemic inflammatory markers (time frame: 1 year later). 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 9 Sep 2025.