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

Purpose

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.

Condition	Intervention	Phase
Multifocal Motor Neuropathy	Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Drug: Placebo: 0.25% human albumin solution (BUMINATE 25%)	Phase III

ChemIDplus related topics:

Globulin, Immune Immunoglobulins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Grip strength in the more affected hand (primary endpoint) [ Time Frame: End of blinded cross-over period ] [ Designated as safety issue: No ]
Upper limb subsection of the Guy's Neurologic Disability Scale (co primary endpoint) [ Time Frame: End of blinded cross-over period ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sequence 1: Experimental Stabilization Phase 1 (IGIV, 10%) -> Randomized Treatment / subjects randomized to Sequence 1: cross-over Period 1 (IGIV, 10%) - Stabilization Phase 2 (IGIV, 10%) - cross-over Period 2 (Placebo) -> Stabilization Phase 3 (IGIV, 10%)	Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Stabilization Phase 1 (12 weeks) with IGIV, 10% (with 3, 4 or 6 intravenous infusions cycles, depending on pre-study treatment) -> Randomized Treatment (36 weeks) / subjects randomized to Sequence 1: cross-over Period 1 (12 weeks) with IGIV, 10%, followed by Stabilization Phase 2 (12 weeks) with IGIV, 10%, followed by cross-over Period 2 (12 weeks) with Placebo -> Stabilization Phase 3 (same treatment as in Stabilization Phase 1) Drug: Placebo: 0.25% human albumin solution (BUMINATE 25%) see Intervention Description for Sequence 1 (IGIV,10%)
Sequence 2: Experimental Stabilization Phase 1 (IGIV, 10%) -> Randomized Treatment / subjects randomized to Sequence 2: cross-over Period 1 - Stabilization Phase 2 (IGIV, 10%)- cross-over Period 2 (IGIV, 10%) -> Stabilization Phase 3 (IGIV, 10%)	Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) Stabilization Phase 1 (12 weeks) with IGIV, 10% (with 3, 4 or 6 intravenous infusions cycles, depending on pre-study treatment) -> Randomized Treatment (36 weeks) / subjects randomized to Sequence 1: cross-over Period 1 (12 weeks) with IGIV, 10%, followed by Stabilization Phase 2 (12 weeks) with IGIV, 10%, followed by cross-over Period 2 (12 weeks) with Placebo -> Stabilization Phase 3 (same treatment as in Stabilization Phase 1) Drug: Placebo: 0.25% human albumin solution (BUMINATE 25%) see Intervention Description for Sequence 2 (IGIV, 10%)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666263

Locations


United States, California
	USC University Hospital	Not yet recruiting
	Los Angeles, California, United States, 90033
	Contact: Said R Beydoun, MD 323-442-8472 sbeydoun@usc.edu
	Principal Investigator: Said R Beydoun, MD
	University of California, San Francisco Medical Center	Not yet recruiting
	San Francisco, California, United States, 94143
	Contact: Jeffrey Ralph, MD 415-353-1994 Jeffrey.Ralph@ucsf.edu
	Principal Investigator: Jeffrey Ralph, MD

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

United States, Kentucky
	Kentucky Neuroscience Research / University of Louisville	Recruiting
	Louisville, Kentucky, United States, 40202
	Contact: Martin E Brown, MD 502-589-6990 ext 276 martin.brown@louisville.edu
	Principal Investigator: Martin E Brown, MD

United States, Maryland
	John Hopkins University	Recruiting
	Baltimore, Maryland, United States, 21287
	Contact: David R Cornblath, MD 410-955-2229 dcornbl@jhmi.edu
	Principal Investigator: David R Cornblath, MD
	University of Maryland, Department of Neurology	Not yet recruiting
	Baltimore, Maryland, United States, 21201-1595
	Contact: James W Russell, MD 410-706-6689 jrussell@som.umaryland.edu
	Principal Investigator: James W Russell, MD

United States, Massachusetts
	Brigham and Women´s Hospital	Not yet recruiting
	Boston, Massachusetts, United States, 02115
	Contact: Anthony Amato, MD 617-732-8081 aamato@partners.org
	Principal Investigator: Anthony Amato, MD

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

United States, New York
	Columbia University	Not yet recruiting
	New York, New York, United States, 10032
	Contact: Louis Weimer, MD 212-305-1516 Lhw1@columbia.edu
	Principal Investigator: Louis Weimer, MD

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

United States, Oregon
	Oregon Health & Science University	Not yet recruiting
	Portland, Oregon, United States, 97239
	Contact: Edward J Cupler, MD 503-418-2125 cuplere@ohsu.edu
	Principal Investigator: Edward J Cupler, MD

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

United States, Utah
	University of Utah	Not yet recruiting
	Salt Lake City, Utah, United States, 84132
	Contact: Mark Bromberg, MD 801-585-5885 mbromberg@hsc.utah.edu
	Principal Investigator: Mark Bromberg, MD

United States, Virginia
	University of Virginia, Department of Neurology	Not yet recruiting
	Charlottesville, Virginia, United States, 22908
	Contact: Lawrence H Phillips, MD 434-924-5361 lhp3n@Virginia.edu
	Principal Investigator: Lawrence H Phillips, MD

Canada, Alberta
	University of Calgary	Not yet recruiting
	Calgary, Alberta, Canada, T2N 4N1
	Contact: Douglas Zochodne, MD 403-220-8831 dzochodn@ucalgary.ca
	Principal Investigator: Douglas Zochodne, MD

Canada, Ontario
	London Health Sciences Centre	Not yet recruiting
	London, Ontario, Canada, N6A 5A5
	Contact: Angelika Hahn, MD 519-663-3110 Angelika.Hahn@lhsc.on.ca
	Principal Investigator: Angelika Hahn, MD
	Queen´s University / Kingston General Hospital	Not yet recruiting
	Kingston, Ontario, Canada, K7L 3N6
	Contact: Michel Melanson, MD 613-549-6666 mm42@post-queensu.ca
	Principal Investigator: Michel Melanson, MD

Canada, Quebec
	McGill University Health Centre / Montreal General Hospital	Not yet recruiting
	Montreal, Quebec, Canada
	Contact: Colin Chalk, MD 514-934-8059 colin.chalk@mcgill.ca
	Principal Investigator: Colin Chalk, MD

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators


Study Director:	Baxter BioScience Investigator	Baxter Healthcare Corporation

More Information

Responsible Party:	Baxter Healthcare Corporation ( Alison Nimchuk, MPH; Clinical Project Manager )
Study ID Numbers:	160604
First Received:	April 23, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00666263
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Motor neuropathy

Neuromuscular Diseases

Immunoglobulins, Intravenous

Peripheral Nervous System Diseases

Rho(D) Immune Globulin

Immunoglobulins

Neuritis

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Nervous System Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00666263