NCT01537575

Brief Summary

Postpolio syndrome is a condition that affects many polio survivors years after the acute infection and causes symptoms to increase or new symptoms to develop. Proinflammatory cytokine production within the central nervous system (CNS) indicates an underlying inflammatory process, amenable to immunomodulatory therapy. In this study the investigators sought to confirm that antiinflammatory treatment with intravenous immunoglobulin improves the disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

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

January 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

1.9 years

First QC Date

February 17, 2012

Last Update Submit

February 23, 2012

Conditions

Post-polio Syndrome

Outcome Measures

Primary Outcomes (1)

  • SF-36 physical component

    Baseline; 2 and 4 months after treatment

Study Arms (2)

saline solution

PLACEBO COMPARATOR
Biological: Saline solution

intravenous immunoglobulins

EXPERIMENTAL
Biological: intravenous immunoglobulins

Interventions

intravenous immunoglobulinsBIOLOGICAL

One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days

intravenous immunoglobulins
Saline solutionBIOLOGICAL

Placebo

saline solution

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a history of acute poliomyelitis
  • increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis
  • a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi

You may not qualify if:

  • clinically relevant systemic disease
  • malignancy
  • hypothyroidism
  • diabetes mellitus not fully controlled by medical therapy
  • medical or orthopedic disorders that could give rise to symptoms mimicking post-polio syndrome
  • conditions associated with prolonged coagulation time
  • serum IgA deficiency
  • previous allergic reaction to IVIG
  • body-mass index greater than 30
  • immune-modulating treatments other than IVIG within the preceding 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postpoliomyelitis Syndrome

Interventions

Immunoglobulins, IntravenousSaline Solution

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 GlobulinsGlobulinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Neurophysiology Unit

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 23, 2012

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Last Updated

February 27, 2012

Record last verified: 2012-02