Polio Survivors' hope dashed: trial of immune treatment halted early
NCT ID NCT02176863
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a blood product called immune globulin (Flebogamma) in 191 people with post-polio syndrome, a condition causing new muscle weakness years after polio. The goal was to see if it could improve walking distance and reduce pain. The trial was terminated early, so we don't have clear answers on whether it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- immune globulin (Flebogamma 5% DIF)
- What this could lead to
- If it worked, this could point toward a treatment to improve walking ability and reduce pain in people with post-polio syndrome.
- What could go wrong
- The trial was terminated early, so results are limited. It was a mid-stage study, and the treatment may not prove effective or safe for wider use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
191 people
The number who actually took part.
- Started
-
Sep 2014
- Finished
-
Nov 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants with Body Mass Index less than 35 kg/m\^2. * Participants who meet the clinical criteria for diagnosis of PPS as set by March-of-Dimes. * Participants who are ambulatory or are able to walk with a cane or other aids or use a wheelchair (but they are not wheelchair-bound). * Participants who have at least 2 newly weakened muscle groups due to PPS (as defined by medical history), with at least 1 of them in a lower extremity, and having a Medical Research Council (MRC) scale score greater than 3 at the Manual Muscle Testing (MMT) performed by the independent assessor at the Screening Visit (SV). * Female of child-bearing potential must have a negative test for pregnancy (Human chorionic gonadotropin (HCG)-based assay). * Female of child-bearing potential and their sexual partners have agreed to practice contraception using a method of proven reliability (i.e., hormonal methods; barrier methods; intrauterine devices methods) to prevent a pregnancy during the course of the clinical trial. * Participants must be willing to comply with all aspects of the clinical trial protocol, including blood sampling and long-term storage of extra samples for the entire duration of the study. * Participants who are able to walk a 2MWD of at least 50 meters at the SV and Enrollment Visit/Infusion Visit 1 (EV/IV1) * Participants who are able to walk a consistent baseline 2 MWD, that is, the difference in 2MWD between the SV and EV/IV1 is not more than 10%. Exclusion Criteria: * Participants who have received human normal immune globulin treatment given by intravenous, subcutaneous, or intramuscular route within the last 3 years. * Participants who are not ambulatory (wheelchair-bound individuals). * Participants with poor venous access. * Participants with intractable pain requiring narcotics or other psychotropic drugs. * Participants with a history of anaphylactic reactions or severe reactions to any blood-derived product. * Participants with a history of intolerance to any component of the investigational products, such as sorbitol. * Participants receiving corticosteroids, except for those who are taking inhaled corticosteroids for asthma. * Participants with a documented diagnosis of hyper viscosity or hypercoagulable state or thrombotic complications to polyclonal intravenous immunoglobulin (IVIG) therapy in the past. * Participants with a history of recent (within the last year) myocardial infarction, stroke, or uncontrolled hypertension. * Participants who suffer from congestive heart failure, embolism, or electrocardiogram changes indicative of unstable angina or atrial fibrillation. * Participants with a history of chronic alcoholism or illicit drug abuse (addiction) in the preceding 12 months prior to the SV. * Participants with active psychiatric illness that interferes with compliance or communication with health care personnel. * Participants with depression with scores \>30 as assessed by the Center for Epidemiologic Studies Depression (CESD) validated scale. * Females who are pregnant or are nursing an infant child. * Participants with any medical condition which makes clinical trial participation unadvisable or which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the clinical trial according to the Investigator's judgment. * Participants currently receiving, or have received within 3 months prior to the SV, any investigational medicinal product or device. * Participants who are unlikely to adhere to the protocol requirements, or are likely to be uncooperative, or unable to provide a storage serum/plasma sample prior to the first investigational drug infusion. * Participants with known selective Immune globulin A class (IgA) deficiency and serum antibodies anti-IgA. * Participants with renal impairment (i.e., serum creatinine exceeds more than 1.5 times the upper limit of normal \[ULN\]) for the expected normal range for the testing laboratory). * Participants with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding more than 2.5 times the ULN. * Participants with hemoglobin levels \<10 g/dL, platelets levels \<100,000 /mm\^3, white blood cells count \<3.0 k/µL, and erythrocyte sedimentation rate \>50 mm/h or twice above normal. * Participants with known seropositive to Hepatitis C virus (HCV), Human immunodeficiency virus-1 (HIV-1) and/or Human immunodeficiency virus-2 (HIV-2). * Participants with a history of intolerance to fructose.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Post-polio syndrome are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Aarhus Universitets Hospital-Neurologisk Forskning
Aarhus N, 8200, Denmark
-
Academisch Medisch Centrum Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ, Netherlands
-
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, 37124, Italy
-
Charité Campus Mitte
Berlin, 10117, Germany
-
Clinical Research Center Sp. z o.o.
Poznan, 60-848, Poland
-
Hannover Medical School
Hanover, 30625, Germany
-
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
-
Institut Guttman
Badalona, 08916, Spain
-
Klinik für konservative Orthopädie und des Poliozentrums
Koblenz, 56073, Germany
-
MedTrials
Krakow, 31-436, Poland
-
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596, United States
-
Montreal Neurological Institute Clinical Research Unit, McGill University
Montreal, Quebec, H3A 2B4, Canada
-
Rigshospitalet
København Ø, 2100, Denmark
-
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
-
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, 02-097, Poland
-
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954, Poland
-
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
-
Thomayerova nemocnice, Klinicko-farmakologická jednotka
Prague, 4, Czechia
-
Universitätsklinikum Jena
Jena, 07747, Germany
-
Washington University
St Louis, Missouri, 63110, United States
-
Westfälische Wilhelms-Universität Münster
Münster, 48149, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.