Intravenous Immunoglobulins for Post-Polio Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Laura Bertolasi, Azienda Ospedaliera Universitaria Integrata Verona

ClinicalTrials.gov Identifier:

NCT01537575

First received: February 17, 2012

Last updated: February 23, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 17, 2012
Last Updated Date	February 23, 2012
Start Date ^ICMJE	January 2008
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 23, 2012)	SF-36 physical component [ Time Frame: Baseline; 2 and 4 months after treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: February 22, 2012)	SF-36 physical component [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01537575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intravenous Immunoglobulins for Post-Polio Syndrome
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Post-polio Syndrome
Intervention ^ICMJE	Biological: intravenous immunoglobulins One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days Biological: Saline solution Placebo
Study Arm (s)	Placebo Comparator: saline solution Intervention: Biological: Saline solution Experimental: intravenous immunoglobulins Intervention: Biological: intravenous immunoglobulins
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	Not Provided
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01537575
Other Study ID Numbers ^ICMJE	EUDRACT-200700-3559-35
Has Data Monitoring Committee	No
Responsible Party	Laura Bertolasi, Azienda Ospedaliera Universitaria Integrata Verona
Study Sponsor ^ICMJE	Azienda Ospedaliera Universitaria Integrata Verona
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Azienda Ospedaliera Universitaria Integrata Verona
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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