NCT02343211

Brief Summary

Paraneoplastic Neurological Syndromes (PNS) are rare remote effects of cancer, not directly attributed to mass lesions, metastases, infections, ischemia, coagulopathy, metabolic disruptions or tumour treatment. Currently, PNS treatment is mostly limited to tumour treatment. Because of an initial inflammatory stage early in the evolution of the PNS several immunotherapy modalities have been tried. Intravenous human immunoglobulins could be expected to provide a stabilization or even improvement of PNS, if administered early enough to prevent permanent neuronal damage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2.6 years

First QC Date

January 15, 2015

Last Update Submit

November 3, 2017

Conditions

Paraneoplastic Neurological Syndromes

Keywords

Paraneoplastic Neurological SyndromesOnconeural antibodiesCancer

Outcome Measures

Primary Outcomes (1)

  • percentage of patients with neurological improvement after 3 months of immunotherapy with IVIg

    "Success" is defined by ≥ 1 point lower score in the modified Rankin Scale (mRS) after treatment compared to baseline. "Failure" is defined by failure to meet the success definition.

    3 months

Secondary Outcomes (8)

  • percentage of patients with neurological improvement after 6 months of immunotherapy with IVIg

    6 months

  • percentage of patients with improvement in Barthel Index (BI)

    3 months

  • percentage of patients with improvement in Barthel Index (BI)

    6 months

  • percentage of patients with improvement in International Cooperative Ataxia Rating Scale (ICARS),

    3 months

  • percentage of patients with improvement in International Cooperative Ataxia Rating Scale (ICARS),

    6 months

  • +3 more secondary outcomes

Study Arms (1)

immunoglobulin

EXPERIMENTAL
Drug: Immunoglobulin

Interventions

ImmunoglobulinDRUG
immunoglobulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitié Salpetrière

Paris, 75013, France

Location

Related Publications (1)

  • Berzero G, Karantoni E, Dehais C, Ducray F, Thomas L, Picard G, Rogemond V, Candelier G, Camdessanche JP, Antoine JC, De Seze J, Liou-Schischmanoff A, Honnorat J, Delattre JY, Psimaras D. Early intravenous immunoglobulin treatment in paraneoplastic neurological syndromes with onconeural antibodies. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):789-792. doi: 10.1136/jnnp-2017-316904. Epub 2017 Oct 30. No abstract available.

    PMID: 29084869DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Immunoglobulins

Intervention Hierarchy (Ancestors)

ImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Dimitri Psimaras, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 21, 2015

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

FR(1)