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
About this trial
This is an interventional treatment trial for Post-Polio Syndrome focused on measuring Post-polio syndrome, IvIg
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
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
NCT ID
NCT00231439
First Posted
September 30, 2005
Last Updated
December 12, 2005
Sponsor
Haukeland University Hospital
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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