Investigating the effects of clozapine on immune function in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines the immunodeficiency effects associated with clozapine treatment in patients with Parkinson's disease experiencing psychotic symptoms. It involves regular monitoring of blood counts to assess the risk of neutropenia and potential infections due to clozapine. The study aims to understand the immunosuppressive effects of clozapine, which may resemble those seen in patients with common variable immunodeficiency. Participants will undergo blood tests weekly for the first 18 weeks and monthly thereafter to ensure safety during treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Amiens-Picardie
  Salouël, France Recruiting

Study contacts

• Study coordinator: Mickaël AUBIGNAT, MD
• Email: aubignat.mickael@chu-amiens.fr
• Phone: 33 + 03 22 66 82 40

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.