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New treatment option for Clozapine
Official title Clozapine-related Immunodeficiency in Parkinsons Disease
ClinicalTrials.gov ID: NCT06634641
What this study is testing
What is blood test?
blood test is an investigational medicine, given as an once-weekly, being studied as a potential treatment for clozapine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 ≥...
- patients in whom the number of white blood cells (WBC) and the absolute number of neutrophils (PNN) may be determined regularly at the following...
- Informed and written consent.
You likely can't join if
- 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...
See the full eligibility 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...
- Informed and written consent.
- Affiliation to a social security system
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Salouël, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salouël, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.