Clozapine-related Immunodeficiency in Parkinsons Disease (NCT06634641) | Clinical Trial Compass
RecruitingPhase 4
Clozapine-related Immunodeficiency in Parkinsons Disease
France24 participantsStarted 2024-10-01
Plain-language summary
Clozapine is a second generation antipsychotic drug used in psychiatry to treat schizophrenia, affective disorders or certain symptoms of dementia. In neurology, clozapine is frequently used and recommended to manage symptoms of psychosis associated with Parkinson's disease (PD). The risk of neutropenia or agranulocytosis associated with clozapine estimated at 1.3% is well known to doctors around the world with a peak at one month and a decrease in risk after more than a year of treatment. This risk has led to the policy of "no blood, no drugs" and monitoring of the complete blood count (CBC) weekly for 18 weeks and then monthly for the duration of treatment.
Some studies suggest an increased risk of infections related to immunodeficiency induced by clozapine itself. This clozapine-induced immunodeficiency would be comparable to that encountered in patients with common variable immunodeficiency or under immunosuppressive treatment. In addition, this immunosuppressive effect linked to clozapine would not be dose dependent but time dependent. However, the only studies currently performed have been in psychiatric patients treated for schizophrenia.
It seems important to specifically explore clozapine-related immunodeficiency in PD patients treated with clozapine for PD-related psychosis. In this study, the investigators propose to evaluate the variations in serum immunoglobulin levels and lymphocyte subpopulations (B, T, NK) in parkinsonian patients treated with Clozapine at 6 months and 1 year after initiation of treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Uncontrol…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically looking at how clozapine affects IgG antibody levels in people with Parkinson's disease — can you explain what low IgG could mean for my immune system, and whether that's something I should already be worried about given my current treatment?
2Since this is a Phase 4 trial, clozapine is already an approved medication — does that mean the safety profile is better understood than an earlier-phase study, and what risks are still being investigated here that I should know about?
3Clozapine is typically used for psychosis in Parkinson's disease — would I need to already be taking clozapine to participate, and if I'm not currently on it, is starting it just to join this trial the right move for my situation?
4If the trial finds that clozapine does lower my IgG levels, what would that actually mean for my care — would I have to stop taking it, and are there other options for managing Parkinson's-related psychosis that we should consider as a backup?
5How often would I need to come in for blood draws or monitoring to track my IgG levels during this study, and is that kind of schedule something that would realistically fit into my life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.