Treatment with 3 drugs against sensitive neuropathies

Phase 1

• Conditions: Paraneoplastic Neurological Syndromes; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-000177-23-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Age = 18 years
-Neuropathic sensory possible according to the criteria of Camdessanché et al.
-Dominant ataxia table (central nervous system involvement and / or neuromuscular junction is allowed, provided it has a minor impact on the patient's disability)
-Anti-Hu antibody positive in blood and / or cerebrospinal fluid
-Outpatient (modified Rankin score 2 or 3)
-First neurological symptoms for less than 3 months
-Free, informed, written and signed consent
-Affiliation to a social security scheme or beneficiary (except AME)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Possible hypersensitivity to any of the study treatments, their metabolites, or any of the excipients
-Absolute contraindications to intravenous immunoglobulin : selective IgA deficiency, known thrombophilia
-Absolute contraindications to cyclophosphamide: vaccination against yellow fever in the 3 months preceding inclusion, acute urinary tract infection, acute spinal cord failure
-Over two courses of IVIG administered within 3 months before recruitment
-Other concomitant immunotherapy
-Other cause of immunodepression (acquired or congenital)
-Treatment with checkpoint inhibitors in progress or completed less than 3 months ago
- Women of childbearing age without effective contraception, pregnant or lactating
-Psychiatric history or general illness that may contraindicate the treatment
-Patients unable to perform the follow-up required by the study
-Patients under guardianship or curatorship
-Patient deprived of liberty by a judicial or administrative decision

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified