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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   up to 75 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231439

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

No publications provided

ClinicalTrials.gov Identifier: NCT00231439     History of Changes
Other Study ID Numbers: HUS1
Study First Received: September 30, 2005
Last Updated: December 12, 2005
Health Authority: Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on May 23, 2013