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Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy

Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multifocal Motor Neuropathy

Intervention: Immune Globulin Intravenous, 10% (Drug); Immune Globulin Intravenous, 10% or Placebo (0.25% human albumin solution) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
Baxter BioScience Investigator, Study Director, Affiliation: Baxter Healthcare Corporation

Summary

The purpose of the study is to evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor Neuropathy.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor Neuropathy

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Grip strength in the more affected hand (primary endpoint)

Upper limb subsection of the Guy's Neurologic Disability Scale (co primary endpoint)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Written informed consent obtained from the subject prior to any study-related

procedures and study product administration

- Diagnosis of definite or probable MMN based on the criteria of the American

Association of Electrodiagnostic Medicine (AAEM). Diagnosis can be based on chart records. a) Hand grip (finger flexor) weakness of MRC grade 4 or less at onset or appearing prior to screening; b) Documented electrophysiological evidence of at least one site with conduction block with definite (50%) or probable (30%) reduction in area-under-the-curve (AUC) of the compound muscle action potential; c) No upper motor signs; d) No bulbar or cranial signs or symptoms; e) No clinically identifiable sensory abnormalities.

- Must be on a stable regimen of IGIV for at least 3 months prior to enrollment

- Treatment interval with IGIV of 2 to 5 weeks (+/- 3 days)

- Dose of IGIV to be 0. 5 to 2. 0 grams per kilogram bodyweight and infusion cycle

- Subjects are adults, male or female, at least 18 years of age

- If female and capable of bearing children - have a negative urine pregnancy test

result at enrollment and agree to employ adequate birth control measures for the duration of the study

- Ability and willingness to travel to the study site for infusions and assessments if

required by the protocol

Exclusion Criteria:

- Any disease that may cause neuropathy or may interfere with outcome assessments, such

as diabetes requiring medication for control or vasculitis, including systemic lupus erythematosis

- Treatment with other immunosuppressive agents besides IGIV during the 3 months prior

to enrollment (or treatment with Rituximab during the 12 months prior to enrollment)

- Cerebrospinal fluid protein > 100 mg/dL (if done as part of a previous evaluation)

- Subjects positive at enrollment for one or more of the following: Hepatitis B surface

antigen (HBsAg), PCR for HCV, PCR for HIV Type 1

- Subjects with levels of alanine aminotransferase (ALT) or aspartate aminotransferase

(AST) > 2. 5 times the upper limit of normal for the testing laboratory

- Subjects with neutropenia (defined as an absolute neutrophil count [ANC] <= 1000/mm3)

- Subjects with serum creatinine levels greater than 1. 5 times the upper limit of

normal for age and gender

- Subjects with malignancy other than adequately treated basal cell or squamous cell

carcinoma of the skin or carcinoma in situ of the cervix

- Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial

infarction, cerebrovascular accident)

- Subjects who received any blood or blood product exposure other than an IGIV,

subcutaneous immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to enrollment

- Subjects with an ongoing history of hypersensitivity or persistent reactions

(urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV

- Subjects with immunoglobulin A (IgA) deficiency and known anti IgA antibodies

- Subjects using another investigational product or device within 30 days prior to

enrollment

- Subjects who are unable or unwilling to meet all the requirements of this study

- If female, is pregnant or lactating at time of enrollment

Locations and Contacts

Aarhus University Hospital, Dept. of Neurology, Aarhus 8000, Denmark; Recruiting
Johannes Jakobsen, MD, Email: Johajako@rm.dk
Johannes Jakobsen, MD, Principal Investigator

University Medical Center Utrecht, Department of Neurology, Utrecht G.03.228, Netherlands; Not yet recruiting
Leonard van den Berg, MD
Leonard van den Berg, MD, Principal Investigator

Nszoz Endomedical, Poznana 61-105, Poland; Not yet recruiting
Wojciech Kozubski, MD
Wojciech Kozubski, MD, Principal Investigator

University of Alabama, Birmingham, Alabama 35294-0017, United States; Active, not recruiting

University of Calgary, Calgary, Alberta T2N 4N1, Canada; Recruiting
Douglas Zochodne, MD, Phone: 403-220-8831, Email: dzochodn@ucalgary.ca
Douglas Zochodne, MD, Principal Investigator

University of California, Irvine, Irvine, California 97239, United States; Completed

USC University Hospital, Los Angeles, California 90033, United States; Recruiting
Said R Beydoun, MD, Phone: 323-442-8472, Email: sbeydoun@usc.edu
Said R Beydoun, MD, Principal Investigator

Stanford University Medical Center, Department of Neurology, Stanford, California 94305, United States; Recruiting
Yuen T So, MD, PhD, Phone: 650-723-5184, Email: ytso@stanford.edu
Yuen T So, MD, PhD, Principal Investigator

1st Allergy & Clinical Research Center, Centennial, Colorado 80112, United States; Recruiting
Isaac Melamed, MD, Phone: 303-773-9000, Email: melamedi@1sthealthcenters.com
Isaac Melamed, MD, Principal Investigator

South Florida Medical Research, Aventura, Florida 33180, United States; Active, not recruiting

Shands Jacksonville Neuroscience Institute, Jacksonville, Florida 32209, United States; Active, not recruiting

University of Miami Miller School of Medicine, Miami, Florida 33136, United States; Recruiting
Khema Sharma, MD, Phone: 305-243-5586, Email: Ksharma@med.miami.edu
Khema Sharma, MD, Principal Investigator

University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Mazen Dimachkie, MD, Phone: 913-588-0649, Email: mdimachkie@kumc.edu
Mazen Dimachkie, MD, Principal Investigator

University of Maryland, Department of Neurology, Baltimore, Maryland 21201-1595, United States; Recruiting
James W Russell, MD, Phone: 410-706-6689, Email: jrussell@som.umaryland.edu
James W Russell, MD, Principal Investigator

Caritas St. Elizabeth┬┤s Medical Center, Boston, Massachusetts 02135, United States; Recruiting
Kenneth Gorson, MD, Phone: 617-789-2375, Email: Kenneth.gorson@caritaschristi.org
Kenneth Gorson, MD, Principal Investigator

Washington University School of Medicine, Department of Neurology, St. Louis, Missouri 63110, United States; Recruiting
Glenn Lopate, MD, Phone: 314-362-6981, Email: lopateg@neuro.wustl.edu
Glenn Lopate, MD, Principal Investigator

Columbia University, New York, New York 10032, United States; Active, not recruiting

Cornell University, New York, New York 10021, United States; Recruiting
Russell Chin, MD, Phone: 646-962-3202, Email: ruc9002@med.cornell.edu
Russell Chin, MD, Principal Investigator

The Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Victoria Lawson, MD, Phone: 614-293-4973, Email: victoria.lawson@osumc.edu
Victoria Lawson, MD, Principal Investigator

Queen┬┤s University / Kingston General Hospital, Kingston, Ontario K7L 3N6, Canada; Recruiting
Michel Melanson, MD, Phone: 613-549-6666, Email: mm42@post-queensu.ca
Michel Melanson, MD, Principal Investigator

London Health Sciences Centre, London, Ontario N6A 5A5, Canada; Recruiting
Angelika Hahn, MD, Phone: 519-663-3110, Email: Angelika.Hahn@lhsc.on.ca
Angelika Hahn, MD, Principal Investigator

Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Edward J Cupler, MD, Phone: 503-418-2125, Email: cuplere@ohsu.edu
Edward J Cupler, MD, Principal Investigator

McGill University Health Centre / Montreal General Hospital, Montreal, Quebec, Canada; Recruiting
Colin Chalk, MD, Phone: 514-934-8059, Email: colin.chalk@mcgill.ca
Colin Chalk, MD, Principal Investigator

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Yadollah Harati, MD, Phone: 713-798-5694, Email: yharati@bcm.tmc.edu
Yadollah Harati, MD, Principal Investigator

University of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Mark Bromberg, MD, Phone: 801-585-5885, Email: mbromberg@hsc.utah.edu
Mark Bromberg, MD, Principal Investigator

University of Washington, Department of Neurology, Seattle, Washington 98195, United States; Recruiting
Michael Weiss, MD, Phone: 206-598-2134, Email: mdweiss@u.washington.edu
Michael Weiss, MD, Principal Investigator

Additional Information

Starting date: September 2008
Last updated: August 23, 2010

Page last updated: October 04, 2010

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