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Parkinson's drug may weaken immunity: new study investigates

NCT ID NCT06634641

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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 Results may not be published yet.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

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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This status has not been confirmed recently, so it may be out of date.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 study looks at whether clozapine, a drug used to treat psychosis in Parkinson's disease, weakens the immune system over time. Researchers will measure immune markers in 24 patients before and after 6 and 12 months of treatment. The goal is to understand infection risks in this specific group.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 24 people

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

Started

Oct 2024

Expected to finish

Sep 2027

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

18 years and older

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: * Patient ≥ 18 years old with Parkinson's disease according to MDS 2015 criteria * Psychotic symptoms requiring treatment with Clozapine * Patients with initially a normal leukocyte count (number of white blood cells ≥ 3500/mm3 \[3.5 x 109/l\] and an absolute neutrophil count PNN ≥ 2000/mm3 \[2 x 109/l\]) * patients in whom the number of white blood cells (WBC) and the absolute number of neutrophils (PNN) may be determined regularly at the following intervals: once a week during the first 18 weeks of treatment and, thereafter, at least every 4 weeks for the duration of the treatment. This monitoring must be continued throughout the treatment and for 4 weeks who follow the complete cessation of CLOZAPINE * Informed and written consent. * Affiliation to a social security system Exclusion Criteria: * Patients with a contraindication to the use of Clozapine according to the summary of product characteristics (SPC) * Hypersensitivity to the active substance or to any of the excipients. * Patients who cannot receive regular blood tests. * History of granulopenia or toxic or idiosyncratic agranulocytosis (unless it results from previous chemotherapy). * History of agranulocytosis induced by CLOZAPINE * Treatment with CLOZAPINE should not be started at the same time as substances known to have a high potential for inducing agranulocytosis; The concomitant administration of depot antipsychotics is not recommended. * Functional bone marrow failure. * Uncontrolled epilepsy. * Alcoholic or induced psychosis, drug intoxication, comatose states. * Circulatory collapse and / or CNS depression regardless of the aetiology. * Severe renal or cardiac disorders (eg: myocarditis). * Active liver disease with nausea, anorexia or jaundice; progressive liver disease, liver failure. * Paralytic ileus. * Patient with another potential cause of immunosuppression * Immunosuppressive or immune modulatory treatment active or stopped for less than 5 years * Anti-epileptic treatment active or stopped for less than 5 years * Chemotherapy active or stopped for less than 5 years * Solid or hematologic cancer active or treated for less than 5 years * Human immunodeficiency virus infection * Already known constitutional immune deficiency * Nephrotic syndrome * Protein-losing enteropathy * A history of radiotherapy * Long-term use of corticosteroids * Patient with potentially major cognitive disorders defined by a MoCA score less than or equal to 23 * Pregnant or breastfeeding women * Patient under guardianship/curatorship or deprived of liberty

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

  • CHU Amiens-Picardie

    RECRUITING

    Salouël, 80480, France

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