NCT00231439

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

December 13, 2005

Status Verified

July 1, 2003

First QC Date

September 30, 2005

Last Update Submit

December 12, 2005

Conditions

Post-Polio Syndrome

Keywords

Post-polio syndromeIvIg

Outcome Measures

Primary Outcomes (3)

  • Pain after three months

  • Fatigue after 3 months

  • Muscle strength after 3 months

Secondary Outcomes (1)

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

Interventions

IvIgDRUG

Eligibility Criteria

Age0 Years - 75 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Post-polio syndrome diagnosed at Dept of Neurology, Haukeland University Hospital Walking ability -

You may not qualify if:

  • Other autoimmune disorders Other ongoing autoimmune therapy Severe cardiopulmonary disease IgA deficiency Previous treatment of IvIg Wheelchair dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postpoliomyelitis Syndrome

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

PoliomyelitisMyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Elisabeth Farbu, MD, PhD

    Stavanger University Hospital, Stavanger, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

August 1, 2003

Study Completion

July 1, 2004

Last Updated

December 13, 2005

Record last verified: 2003-07