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Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-polio Syndrome (FORCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Grifols Biologicals Inc.
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. ) Identifier:
First received: June 25, 2014
Last updated: April 5, 2016
Last verified: April 2016

This is a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in subjects with post polio syndrome (PPS).

The main purpose of this study is to select a dose of Flebogamma 5% DIF and confirm the efficacy of the selected Flebogamma 5% DIF dose by assessing physical performance, as measured by 2 Minutes Walk Distance (2MWD) test.

Condition Intervention Phase
Post-polio Syndrome
Biological: Flebogamma 5% DIF
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Parallel‑Group Clinical Trial to Assess the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-Polio Syndrome

Resource links provided by NLM:

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • Change from baseline in 2MWD [ Time Frame: Baseline, Week 52 ]

Secondary Outcome Measures:
  • Change from baseline in Visual Analogue Scale (VAS) of pain [ Time Frame: Baseline, Week 52 ]
  • Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) [ Time Frame: Baseline, Week 52 ]
  • Change from baseline in Six Minutes Walk Distance (6MWD) [ Time Frame: Baseline, Week 52 ]

Other Outcome Measures:
  • Muscle Strength of two newly weakened muscle groups (MMT using the MRC scale) [ Time Frame: Baseline, Week 52 ]
  • Muscle strength of two newly weakened muscle groups (QMT using a dynamometer) [ Time Frame: Baseline, Week 52 ]
  • Walking activity in daily life (pedometer) [ Time Frame: Baseline, Week 52 ]
  • Fatigue (FSS) [ Time Frame: Baseline, Week 52 ]
  • HRQoL (SF-36 MCS) [ Time Frame: Baseline, Week 52 ]
  • Blood and CSF (CSF is optional) inflammatory cytokines [ Time Frame: Baseline, Week 52 ]
  • Sustained effect of Flebogamma 5% DIF compared to placebo [ Time Frame: Baseline, Week 76 ]

    Sustained effect of Flebogamma® 5% DIF compared to placebo as measured by:

    • Physical performance (2MWD) from baseline to FU3 (Week 64) and to the FV (Week 76).
    • Pain (VAS of pain) from baseline to FU3 and to the FV.
    • HRQoL (SF-36 PCS) from baseline to FU3 and to the FV.
    • Endurance (6MWD) from baseline to FU3 and to the FV
    • Muscle strength (MMT using the MRC scale) from baseline to the FV.
    • Muscle strength (QMT using a dynamometer) from baseline to the FV.
    • Walking activity in daily life (pedometer) from baseline to the FV.
    • Fatigue (FSS) from baseline to the FV.
    • HRQoL (SF-36 MCS) from baseline to FU3 and to the FV.
    • Blood and CSF (CSF is optional) inflammatory cytokines from baseline to the FV.

Estimated Enrollment: 210
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 g/kg Flebogamma 5% DIF
Flebogamma 5% DIF, 2 g/kg, intravenous infusion every 4 weeks over two days for 52 weeks
Biological: Flebogamma 5% DIF
Human plasma-derived immunoglobulin
Other Name: immune globulin intravenous (human)
Experimental: 1 g/kg Flebogamma 5% DIF
Flebogamma 5% DIF, 1 g/kg, intravenous infusion every 4 weeks over two days for 52 weeks
Biological: Flebogamma 5% DIF
Human plasma-derived immunoglobulin
Other Name: immune globulin intravenous (human)
Placebo Comparator: Placebo
Normal Saline Solution, matching volume, intravenous infusion every 4 weeks over two days for 52 weeks
Other: Placebo
Normal saline solution

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • BMI less than 35 kg/m2.
  • March-of-Dimes clinical criteria for diagnosis of PPS.
  • Ambulatory or are able to walk with a cane or other aids.
  • Have at least two newly weakened muscle groups, and one of them in a lower extremity, as defined by medical history and having a mMRC scale score of 3 or greater.
  • Female of child-bearing potential must have a negative test for pregnancy.
  • Female of child-bearing potential and their sexual partners have agreed to practice contraception using a method of proven reliability.
  • Able to walk a 2MWD of at least 50 meters.
  • Subjects 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:

  • Have received immune globulin treatment given by intravenous, subcutaneous or intramuscular route within the last 3 years.
  • Are not ambulatory (wheelchair-bound individuals).
  • Poor venous access.
  • Intractable pain requiring narcotics or other psychotropic drugs.
  • History of anaphylactic reactions or severe reactions to any blood-derived product.
  • History of intolerance to any component of the investigational products, such as sorbitol.
  • Receiving corticosteroids, except for those for asthma.
  • Documented diagnosis of hyperviscosity or hypercoagulable state or thrombotic complications to polyclonal IVIG therapy in the past.
  • History of recent (within the last year) myocardial infarction, stroke, or uncontrolled hypertension.
  • Suffer from congestive heart failure, embolism, or electrocardiogram changes indicative of unstable angina or atrial fibrillation.
  • History of chronic alcoholism or illicit drug abuse (addiction) in the preceding 12 months.
  • Active psychiatric illness that interferes with compliance or communication with health care personnel.
  • Depression with scores >30 as assessed by the Center for Epidemiologic Studies Depression validated scale.
  • Females who are pregnant or are nursing an infant child.
  • Currently receiving, or have received within 3 months prior to the Screening Visit, any investigational medicinal product or device.
  • Known selective IgA deficiency and serum antibodies anti-IgA.
  • Renal impairment (i.e., serum creatinine exceeds more than 1.5 time the upper limit of normal (ULN).
  • Subjects with aspartate aminotransferase or alanine aminotransferase levels exceeding more than 2.5 times the ULN.
  • Hemoglobin levels <10 mg/dL, platelets levels <100,000/mm3, white blood cells count <3.0 k/µL and ESR >50 mm/h or twice above normal.
  • Known seropositive to Hepatitis C virus, Human immunodeficiency virus-1 and/or -2.
  • Subjects with a history of intolerance to fructose.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02176863

Contact: Sandra Camprubi
Contact: Karen Rucker

United States, California
University of California Not yet recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Susan Perlman, MD         
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Michele Wells, RN, BSN    314-747-1643   
Principal Investigator: Martin Wice, MD         
United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Courtney Goodrich    315-464-6409   
Principal Investigator: Burke Jubelt, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Lauren E Fedor    215-955-4663   
Principal Investigator: Marinos Dalakas         
Canada, Quebec
Montreal Neurological Institute, McGill University Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Marc Lemieux, MSc, CCRC    514-398-2667   
Principal Investigator: Daria Trojan, MD         
Aarhus Universitets Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Anita Mogensen   
Contact: Anne Sofie Kjaer   
Principal Investigator: Henning Andersen, MD         
Rigshospitalet Recruiting
København Ø, Denmark, 2100
Contact: Anette Anberg   
Principal Investigator: Johannes Klitgaard Jakobsen, MD         
Charité Campus Mitte Recruiting
Berlin, Germany, 10117
Contact: Eileen Dominick    +49 30 450 560 116   
Principal Investigator: Katrin Hahn, MD         
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Chantal Fischer    '+49 (0) 511 532-8333   
Principal Investigator: Susanne Petri, MD         
Universitätsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Julian Grosskreutz, MD    0049 3641 9323488   
Principal Investigator: Julian Grosskreutz, MD         
Westfälische Wilhelms-Universität Münster Recruiting
Münster, Germany, 48129
Contact: Angelika Okegwo    0049 251 8348335   
Principal Investigator: Peter Young, MD         
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi Recruiting
Verona, Italy, 37134
Contact: Maria Tozzi   
Principal Investigator: Laura Bertolasi, MD         
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Eric Voorn, PhD   
Contact: Tamar Gibson    300169184   
Principal Investigator: Frans Nollet, MD         
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Not yet recruiting
Krakow, Poland, 31-503
Contact: Jan Banach    0048 12 424 86 00   
Principal Investigator: Marta Banach, MD         
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Recruiting
Lublin, Poland, 20-954
Contact: Urszula Chyrchel    +48817244720   
Principal Investigator: Konrad Rejdak, MD         
Centrum Medyczne HCP Lecznictwo Stacjonarne Recruiting
Poznan, Poland, 61-485
Contact: Karolina Stryczynska-Piasecka    +48618311786   
Principal Investigator: Jaroslaw Wronka, MD         
Samodzielny Publiczny Centralny Szpital Kliniczny Recruiting
Warsaw, Poland, 02-097
Contact: Malgorzata Gawel    '48 22 599 28 58   
Principal Investigator: Anna Kaminska, MD         
Spitalul Clinic Colentina Recruiting
Bucharest, Romania, 020125
Contact: Cristina Baetu    +40724384031   
Principal Investigator: Ioan Buraga, MD         
Institut Guttman Cami Can Ruti Not yet recruiting
Barcelona, Spain
Principal Investigator: Enric Portell         
Högsbo Sjukhus Not yet recruiting
Göteborg, Sweden, 41345
Principal Investigator: Katharina Stibrant Sunnerhagen         
Universitetssjukhuset Örebro Not yet recruiting
Orebro, Sweden, 70185
Principal Investigator: Ulla-Britt Gripenstedt, MD         
Danderyds Sjukhus AB Not yet recruiting
Stockholm, Sweden, 18288
Principal Investigator: Kristian Borg, MD         
Sponsors and Collaborators
Instituto Grifols, S.A.
Principal Investigator: Marinos Dalakas Coordinating Investigator
  More Information

Responsible Party: Instituto Grifols, S.A. Identifier: NCT02176863     History of Changes
Other Study ID Numbers: IG1104
Study First Received: June 25, 2014
Last Updated: April 5, 2016

Keywords provided by Grifols Biologicals Inc.:
post-polio syndrome
Immune Globulin Intravenous

Additional relevant MeSH terms:
Postpoliomyelitis Syndrome
Pathologic Processes
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neurodegenerative Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on May 23, 2017