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Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

Primary Purpose

Post-Polio Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IvIg
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Polio Syndrome focused on measuring Post-polio syndrome, IvIg

Eligibility Criteria

0 Years - 75 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Post-polio syndrome diagnosed at Dept of Neurology, Haukeland University Hospital Walking ability - Exclusion Criteria: Other autoimmune disorders Other ongoing autoimmune therapy Severe cardiopulmonary disease IgA deficiency Previous treatment of IvIg Wheelchair dependence

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pain after three months
    Fatigue after 3 months
    Muscle strength after 3 months

    Secondary Outcome Measures

    Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum

    Full Information

    First Posted
    September 30, 2005
    Last Updated
    December 12, 2005
    Sponsor
    Haukeland University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00231439
    Brief Title
    Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)
    Official Title
    Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2003
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Haukeland University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Inflammatory cytokines in the cerebrospinal fluid may contribute to the new muscle weakness, fatigue and pain experienced by patients with post-polio syndrome. Intravenousimmunoglobulin (IvIg) reduces this inflammation. The purpose of this study is to investigate the clinical effect of IvIg in post-polio syndrome.
    Detailed Description
    Post-polio syndrome (PPS) is characterised by new muscle weakness, pain, and fatigue several years after the attack of acute polio. This leads to increased disability, and up to now only supportive therapy is available. Patients with PPS lose more motor neurons than expected and surviving neurons fail to maintain neurogenic supply to enlarged motor units. New data report an increased level of inflammatory cytokines in the cerebrospinal fluid (CSF). Immune modulating therapy like IvIg could be an option and this pilot study is the first to investigate the clinical effect of IvIg in PPS. In addition, levels of cytokines in CSF and serum before and after treatment will be investigated.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    IvIg
    Primary Outcome Measure Information:
    Title
    Pain after three months
    Title
    Fatigue after 3 months
    Title
    Muscle strength after 3 months
    Secondary Outcome Measure Information:
    Title
    Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    75 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Post-polio syndrome diagnosed at Dept of Neurology, Haukeland University Hospital Walking ability - Exclusion Criteria: Other autoimmune disorders Other ongoing autoimmune therapy Severe cardiopulmonary disease IgA deficiency Previous treatment of IvIg Wheelchair dependence
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elisabeth Farbu, MD, PhD
    Organizational Affiliation
    Stavanger University Hospital, Stavanger, Norway
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

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