Immunotherapy and Paraneoplastic Neurological Syndromes

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02343211
• Date of registration: 15/01/2015
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Immunotherapy and Paraneoplastic Neurological Syndromes IaSON
• Scientific title: Early Onset Immunotherapy by Intravenous Immunoglobulin in Well-characterized Onconeural-antibody-positive Paraneoplastic Neurological Syndromes
• Date of first enrolment: November 2013
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02343211
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Dimitri Psimaras, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion criteria :

- Age = 18 years

- Clinical diagnosis of PNS according to published criteria

- Positive well-characterized onconeural antibodies (Hu, Yo, CV2/CRMP5) in serum or CSF
samples

- Rankin score between 2 and 4

- Less than 6 months since onset of symptoms

- Less than 3 weeks in a Rankin score between 2 and 3

- Patients who have given written informed consent

Exclusion criteria :

- Patients not be able to receive IVIg

- Patients who receive or will receive concomitant immunotherapy different from that in
the protocol

- Patients with known selective deficiency of IgA

- Women of childbearing potential who are pregnant or lactating, seeking pregnancy or
failing to take adequate contraceptive precautions

- Patients with psychiatric or systemic diseases that prevent the proposed treatment

- Patients who will not be able to attend the required follow-up visits

- Renal, hepatic or cardiac insufficiency, coagulopathy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Paraneoplastic Neurological Syndromes

Intervention(s)

Drug: Immunoglobulin

Primary Outcome(s)

percentage of patients with neurological improvement after 3 months of immunotherapy with IVIg [Time Frame: 3 months]

Secondary Outcome(s)

percentage of patients with improvement in Barthel Index (BI) [Time Frame: 3 months]

percentage of patients with improvement in Overall Neuropathy Limitations Scale (ONLS) [Time Frame: 3 months]

percentage of patients with improvement in Overall Neuropathy Limitations Scale (ONLS) [Time Frame: 6 months]

percentage of patients with improvement in International Cooperative Ataxia Rating Scale (ICARS), [Time Frame: 6 months]

percentage of patients with improvement in International Cooperative Ataxia Rating Scale (ICARS), [Time Frame: 3 months]

Progression-free survival [Time Frame: 6 months]

percentage of patients with neurological improvement after 6 months of immunotherapy with IVIg [Time Frame: 6 months]

percentage of patients with improvement in Barthel Index (BI) [Time Frame: 6 months]

Secondary ID(s)

P120101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors