protocolSection identificationModule nctId: NCT06373211, orgStudyIdInfo id: APHP230701, secondaryIdInfos id: 2023-506942-22-01, type: OTHER, domain: CTIS, briefTitle: Early Immunotherapy With Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy, acronym: NESPA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: 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. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months., conditionsModule conditions: Paraneoplastic Sensory Neuronopathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Immunoglobulins IV (CLAYRIG), interventions name: Cyclophosphamide IV, interventions name: Methylprednisolone IV, outcomesModule primaryOutcomes measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months, secondaryOutcomes measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 and 6 months, secondaryOutcomes measure: Percentage of patients with improvement in the ataxic component on the Score of Ataxia scale at 3 and 6 months, secondaryOutcomes measure: Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months, secondaryOutcomes measure: Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months, secondaryOutcomes measure: Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months, secondaryOutcomes measure: Percentage of patients alive and without tumor progression at 6 months, secondaryOutcomes measure: Tolerance to treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Pitié-Salpêtrière, city: Paris, zip: 75013, country: France, contacts name: Dimitri Psimaras, MD, role: CONTACT, email: dimitri.psimaras@aphp.fr, contacts name: Alice LEPRINCE-LAURENGE, MD, role: CONTACT, email: alice.laurenge@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False