Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

This study has been completed.
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00231439
First received: September 30, 2005
Last updated: December 12, 2005
Last verified: July 2003

September 30, 2005
December 12, 2005
August 2003
Not Provided
  • Pain after three months
  • Fatigue after 3 months
  • Muscle strength after 3 months
Same as current
Complete list of historical versions of study NCT00231439 on ClinicalTrials.gov Archive Site
Pain, Fatigue, Muscle strength after 6 months. Changes in cytokine levels in CSF and serum
Same as current
Not Provided
Not Provided
 
Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)
Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Post-Polio Syndrome
Drug: IvIg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2004
Not Provided

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

Both
up to 75 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00231439
HUS1
Not Provided
Not Provided
Haukeland University Hospital
Not Provided
Study Chair: Elisabeth Farbu, MD, PhD Stavanger University Hospital, Stavanger, Norway
Haukeland University Hospital
July 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP