A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis

Status: Completed
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: No
View:

• Anti-acetylcholine receptor (AChR) antibody positive

• Confirmed diagnosis of generalized myasthenia gravis (MG).

• Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa inclusive at Screening.

• QMG >= 10 at Screening. Note: Subjects who only have a history of ocular MG may not enroll.

• Receiving standard of care MG treatment at a stable dose consisting of any one of the following for the time intervals delineated below (time intervals apply to medications and maintenance of stable dose level):

• Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening and no immunosuppressants

• Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening AND/OR only one of the following:

• Prednisone (up to 60 mg/day or equivalent) for at least 2 months prior to Screening, OR

• Azathioprine for at least 6 months prior to Screening, OR

• Mycophenolate mofetil for at least 6 months prior to Screening, OR

• Methotrexate for at least 6 months prior to Screening, OR

• Cyclosporine or tacrolimus for at least 3 months prior to Screening

• Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening AND/OR prednisone (up to 60 mg/day or equivalent) for at least one month prior to Screening and only one of the following:

• Azathioprine for at least 6 months prior to Screening, OR

• Mycophenolate mofetil for at least 6 months prior to Screening, OR

• Methotrexate for at least 6 months prior to Screening, OR

• Cyclosporine or tacrolimus for at least 3 months prior to Screening

Locations
United States
Arizona
Phoenix Neurological Associates, Ltd.
Phoenix
California
University of California-Irvine
Orange
Connecticut
Yale University School of Medicine
New Haven
Florida
University of Florida Health Science Center
Jacksonville
University of South Florida
Tampa
Georgia
Georgia Regents University
Augusta
Indiana
Indiana University
Indianapolis
Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City
New Jersey
Rutgers New Jersey Medical School
Newark
New York
Columbia University Medical Center
New York
Ohio
Ohio State University Wexner Medical Center
Columbus
Pennsylvania
Thomas Jefferson University Hospital
Philadelphia
Texas
Houston Methodist Neurological Institute
Houston
Vermont
University of Vermont Medical Center
Burlington
Washington
University of Washington Medical Center
Seattle
Other Locations
Belgium
UZ Leuven
Leuven
Canada
London Health Sciences Centre - University Hospital
London
University Health Network (UHN) - Toronto General Hospital
Toronto
Estonia
East Tallinn Central Hospital
Tallinn
France
Hopital Neurologique Pierre Wertheimer, Neuro-musculaire - Electromyographie
Bron Cedex
CHU Nice - Hôpital de l'Archet 1, Ctre de Réf Maladies Neuromusculaires et SLA
Nice Cedex 3
CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique
Strasbourg Cedex
CHU de Toulouse - Hôpital Purpan, Service de Neurologie Générale
Toulouse Cedex 9
Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden
Universitaetsmedizin Göttingen, Parent
Göttingen
Krankenhaus Martha-Maria Halle-Doelau, Klinik fuer Neurologie
Halle
Universitaetsklinikum Hamburg-Eppendorf, Klinik und Poliklinik fuer Neurologie
Hamburg
Universitaetsklinikum Jena, Klinik fuer Neurologie
Jena
Universitaetsklinikum Koeln, Neurologie und Psychiatrie
Koeln
Universitaetsklinikum Regensburg, Parent
Regensburg
Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Neurologiai Osztaly
Budapest
Pest Megyei Flor Ferenc Korhaz, Neurologia es Stroke Osztaly
Kistarcsa
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas
Poland
Uniwersyteckie Centrum Kliniczne, Dept of Neurology
Gdansk
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
Krakow
III Szpital Miejski w Lodzi im. Dr K. Jonschera
Lodz
Samodzielny Publiczny Centralny Szpital Kliniczny, Dept of Neurology
Warszawa
Time Frame
Start Date: August 2015
Completion Date: January 2018
Participants
Target number of participants: 62
Treatments
Experimental: IGIV-C
IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.~An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).
Placebo Comparator: Placebo
Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).
Sponsors
Leads: Grifols Therapeutics LLC

This content was sourced from clinicaltrials.gov

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