Clozapine-related Immunodeficiency in Parkinson's Disease

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of clozapine, a medication commonly used to treat psychosis in people with Parkinson's disease (PD). Researchers want to understand how clozapine may affect the immune system in these patients, particularly looking at levels of certain immune proteins and types of immune cells over time. Clozapine can sometimes cause a drop in white blood cells, which can increase the risk of infections, so the study aims to explore whether this immunodeficiency is a concern for those with PD.

To participate in this trial, individuals must be at least 18 years old, have a diagnosis of Parkinson's disease, and experience psychotic symptoms that require treatment with clozapine. They should also have normal blood cell counts at the start of the study and be willing to undergo regular blood tests throughout the treatment period. Participants can expect close monitoring, with blood tests conducted weekly for the first 18 weeks and then monthly after that. This study is important because it aims to provide more information about the safety of clozapine in people with Parkinson's disease, helping doctors make better treatment decisions.

Gender

ALL

Eligibility criteria

• 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