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Could an Anti-Inflammatory pill slow Parkinson's?

NCT ID NCT07157735

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether dapansutrile, a drug that targets inflammation, is safe and can reduce brain and body inflammation in people with early Parkinson's disease. 36 participants will take either the drug or a placebo daily for 6 months, with brain scans and spinal taps to measure effects. The goal is to see if calming inflammation might help modify the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapansutrile
What this could lead to
If it works, this could point toward a new way to slow Parkinson's progression by targeting inflammation.
What could go wrong
This is a small early-phase trial with only 36 people, so results may not apply widely. The drug may not reduce inflammation or improve symptoms, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: To be included in the trial, the potential participant must: * Have given written informed consent to participate. * Be aged between 50 and 80 years (inclusive) at the time of the screening visit. * Be a fluent English speaker. * Have a diagnosis of clinically established early PD according to the Movement Disorder Society Criteria for Clinically Established Early Parkinson's Disease. * Have a disease duration of less than 5 years at the time of screening visit. * Have early-stage PD, defined as Hoehn and Yahr stage ≤2. * Be PD drug naïve or be receiving a stable dose of dopaminergic therapy for at least 3 months prior to screening visit, or between screening and baseline. * Have hsCRP ≥ 1 mg/L on a blood test done within 2 years prior to, or at, the screening visit. * Have adequate organ function, as defined below (to be rechecked prior to baseline/investigational medicinal product \[IMP\] initiation if \>42 days from screening visit): Haemoglobin ≥ 110 g/L; Platelet count ≥ 130 × 109/L; Neutrophil count ≥ 1.5 × 109/L; Renal function: estimated glomerular filtration rate (eGFR) \>45 mL/min/1.73m2; Hepatic function: alanine aminotransferase (ALT) and bilirubin \< 1.5 times the institutional upper limit of normal; Thyroid function: thyroid stimulating hormone (TSH) within normal range; or if TSH is abnormal, free T4 within normal range; Corrected calcium ≤ institutional upper limit of normal; Alkaline phosphatase (ALP) \< 1.5 times the institutional upper limit of normal Exclusion Criteria: The presence of any of the following will preclude inclusion: * Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971. * Any use of immunomodulatory drugs or biologic agents (such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide etc.) within 12 months prior to screening visit, or between screening and baseline. * Any previous use of rituximab or alemtuzumab at any time. * Treatment with oral corticosteroids for greater than 2 weeks within 12 months prior to screening visit, or any oral or injected steroid use within 3 months prior to screening visit, or between screening and baseline. * Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin \> 75 mg, naproxen, ibuprofen and meloxicam - on more than 2 days per week. * Clinically significant inflammatory or autoimmune disease. * Chronic or latent infection. * Severe infection requiring the use of parenteral antimicrobial agents within 2 months prior to screening visit, or between screening and baseline. * Skin, solid organ or haematological malignancy which is active\* at screening, or between screening and baseline (\*defined as cancer which is under active management, with the exception of low-grade malignancy under observation of hormonal treatment). * The inability to take or swallow oral medication. * Parkinson's Disease Dementia according to Movement Disorder Society (MDS) PD Dementia criteria. * A known genetic mutation associated with PD. * A positive test for human immunodeficiency virus (HIV), hepatitis B (HBV)/C (HCV) or syphilis. * Chronic liver disease. * Any concurrent medical or psychiatric condition or disease that is likely to interfere with the trial procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this trial. * Women of childbearing potential - female participants must be surgically sterile or be post-menopausal. (A post-menopausal state is defined as no menses for 12 months without an alternative medical cause). * Male participants must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after the last dose of the trial treatment. * Known hypersensitivity to dapansutrile or its excipients. * Received an investigational drug or used an invasive investigational medical device within 12 weeks before the screening assessment, or is currently enrolled in another interventional investigational trial. Participants currently enrolled in other observational studies may be recruited. * Contraindications to PET-magnetic resonance imaging (MRI) scanning including metal implants, claustrophobia or inability to lie flat for 90 minutes. * Concomitant treatment with any medications that could interfere with \[18F\]-DPA714 binding (e.g., certain benzodiazepines), with the exception of medications which can be safely withheld for an appropriate washout period prior to imaging at the investigator's discretion. * Current use of any drugs of abuse or average alcohol intake of \>21units per week over the last 3 months. * Any other significant disease, disability or investigation result which, in the opinion of the Chief Investigator (CI), may either put the participant at risk, or may influence the result of the trial, or the participant's ability to participate in the trial.

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Conditions

The condition(s) this trial relates to.

Inflammation Nerve Degeneration Neuroinflammatory Diseases Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • John Van Geest Centre for Brain Repair

    RECRUITING

    Cambridge, CB2 0PY, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.