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New treatment option for Paraneoplastic Sensory Neuronopathy
Official title Early Immunotherapy with Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients with Anti-Hu-associated Paraneoplastic Sensory Neuronopathy
ClinicalTrials.gov ID: NCT06373211
What this study is testing
What is Immunoglobulins IV (CLAYRIG)?
Immunoglobulins IV (CLAYRIG) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for paraneoplastic sensory neuronopathy.
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
- Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy.
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years old
- "Possible" sensory neuronopathy according to the criteria of Camdessanché et al. [2] with ONLS score ≥ 1
- Dominant picture of sensory ataxia (damage to the central nervous system and/or the neuromuscular junction is allowed, provided that it has a minor...
- Positive anti-Hu antibodies in blood and/or cerebrospinal fluid
- Outpatient (modified Rankin Score (mRS) 2 or 3)
You likely can't join if
- Known hypersensitivity to one of the treatments under study, to their metabolites, or to one of the excipients
- Absolute contraindications to IVIg: selective IgA deficiency, known thrombophilia, patients suffering from type I or II hyperprolinemia...
- Absolute contraindications to cyclophosphamide: vaccination against yellow fever in the 3 months preceding inclusion, acute urinary infection...
- Contraindication to methylprednisolone: live vaccines, or live attenuated vaccines within 3 months, infectious state or evolving virus (hepatitis...
- More than two courses of IVIg administered within 3 months before recruitment
- Other concomitant immunotherapy
See the full eligibility criteria
- Age ≥ 18 years old
- "Possible" sensory neuronopathy according to the criteria of Camdessanché et al. [2] with ONLS score ≥ 1
- Dominant picture of sensory ataxia (damage to the central nervous system and/or the neuromuscular junction is allowed, provided that it has a minor impact on the patient's disability)
- Positive anti-Hu antibodies in blood and/or cerebrospinal fluid
- Outpatient (modified Rankin Score (mRS) 2 or 3)
- Onset of neurological symptoms less than 3 months ago
- Free, informed, written and signed consent
- Affiliation to a social security or beneficiary scheme (except AME)
- Known hypersensitivity to one of the treatments under study, to their metabolites, or to one of the excipients
- Absolute contraindications to IVIg: selective IgA deficiency, known thrombophilia, patients suffering from type I or II hyperprolinemia, hypersensitivity to human immunoglobulins
- Absolute contraindications to cyclophosphamide: vaccination against yellow fever in the 3 months preceding inclusion, acute urinary infection, pre-existing hemorrhagic cystitis, urinary tract obstruction, acute bone...
- Contraindication to methylprednisolone: live vaccines, or live attenuated vaccines within 3 months, infectious state or evolving virus (hepatitis, herpes, chickenpox, shingles)
- More than two courses of IVIg administered within 3 months before recruitment
- Other concomitant immunotherapy
- Other cause of immunosuppression (acquired or congenital)
- Treatment with checkpoint inhibitors in progress or completed less than 3 months previously
- Woman or man without effective contraception
- Pregnant or breastfeeding woman
- History of psychiatric or general illnesses that may contraindicate treatment
- Patients unable to complete the follow-up required by the study
- Patients under guardianship or curatorship
- Patient deprived of liberty by a judicial or administrative decision
The study team makes the final eligibility decision.
Where it's taking place
- Paris, 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 Paris, 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.