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NCT Number: NCT00231439

Post-Poliosyndrome 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.

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Key information

Conditions

Post-Polio Syndrome Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Myelitis Nervous System Diseases Neurodegenerative Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis Postpoliomyelitis Syndrome RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

0 year–75 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVIG

Drug

Primary outcomes

  1. Pain after three months

  2. Fatigue after 3 months

  3. Muscle strength after 3 months

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

Post-Polio Syndrome Treated With Intravenous Immunoglobulin (IvIg)

Important dates

Study start
2003
Study completion
2004
First posted
Oct 4, 2005
Registry last updated
Dec 13, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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