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Intravenous Immunoglobulins for Post-Polio Syndrome

Primary Purpose

Post-polio Syndrome

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
intravenous immunoglobulins
Saline solution
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-polio Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a history of acute poliomyelitis
  • increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis
  • a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi

Exclusion Criteria:

  • clinically relevant systemic disease
  • malignancy
  • hypothyroidism
  • diabetes mellitus not fully controlled by medical therapy
  • medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome
  • conditions associated with prolonged coagulation time
  • serum IgA deficiency
  • previous allergic reaction to IVIG
  • body-mass index greater than 30
  • immune-modulating treatments other than IVIG within the preceding 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    saline solution

    intravenous immunoglobulins

    Arm Description

    Outcomes

    Primary Outcome Measures

    SF-36 physical component

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2012
    Last Updated
    February 23, 2012
    Sponsor
    Azienda Ospedaliera Universitaria Integrata Verona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01537575
    Brief Title
    Intravenous Immunoglobulins for Post-Polio Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliera Universitaria Integrata Verona

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-polio Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    saline solution
    Arm Type
    Placebo Comparator
    Arm Title
    intravenous immunoglobulins
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    intravenous immunoglobulins
    Intervention Description
    One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days
    Intervention Type
    Biological
    Intervention Name(s)
    Saline solution
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    SF-36 physical component
    Time Frame
    Baseline; 2 and 4 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a history of acute poliomyelitis increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi Exclusion Criteria: clinically relevant systemic disease malignancy hypothyroidism diabetes mellitus not fully controlled by medical therapy medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome conditions associated with prolonged coagulation time serum IgA deficiency previous allergic reaction to IVIG body-mass index greater than 30 immune-modulating treatments other than IVIG within the preceding 6 months

    12. IPD Sharing Statement

    Learn more about this trial

    Intravenous Immunoglobulins for Post-Polio Syndrome

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