We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00231439
First Posted: October 4, 2005
Last Update Posted: December 13, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Haukeland University Hospital
  Purpose
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.

Condition Intervention Phase
Post-Polio Syndrome Drug: IvIg Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

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

Estimated Enrollment: 40
Study Start Date: August 2003
Estimated Study Completion Date: July 2004
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 75 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231439


Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Chair: Elisabeth Farbu, MD, PhD Stavanger University Hospital, Stavanger, Norway
  More Information

ClinicalTrials.gov Identifier: NCT00231439     History of Changes
Other Study ID Numbers: HUS1
First Submitted: September 30, 2005
First Posted: October 4, 2005
Last Update Posted: December 13, 2005
Last Verified: July 2003

Keywords provided by Haukeland University Hospital:
Post-polio syndrome
IvIg

Additional relevant MeSH terms:
Syndrome
Postpoliomyelitis Syndrome
Disease
Pathologic Processes
Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs