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

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

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

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

Resource links provided by NLM:

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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:	September 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stabilization Phases 1, 2, 3: Experimental Stabilization Phases 1, 2, 3 (with Cross-Over Period 1 between Stabilization Phases 1 and 2 and Cross-Over Period 2 between Stabilization Phases 2 and 3): open label - all patients - Immune Globulin Intravenous, 10% at the same dose and frequency as prior to entering the study - length: 12 weeks	Drug: Immune Globulin Intravenous, 10% Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific)
Cross-Over Periods 1,2: Experimental Cross-Over Periods 1, 2: randomized - double-blinded - length: maximum of 12 weeks with ability to move to next stabilization phase early if deterioration occurs	Drug: Immune Globulin Intravenous, 10% or Placebo (0.25% human albumin solution) Cross-over Period 1 (Randomized) / Cross-over Period 2 (opposite of the treatment received in Cross-over Period 1); Dose: Same volume/frequency as Stabilization Phase 1

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

Show 24 Study Locations

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Baxter BioScience Investigator

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation ( Alison Nimchuk, MPH; Clinical Project Manager )
Study ID Numbers:	160604
Study First Received:	April 23, 2008
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00666263 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Antibodies
Immunologic Factors
Neuromuscular Diseases
Immunoglobulins, Intravenous
Peripheral Nervous System Diseases

Rho(D) Immune Globulin
Motor Neuropathy
Immunoglobulins
Neuritis

Additional relevant MeSH terms:

Antibodies
Immunologic Factors
Neuromuscular Diseases
Immunoglobulins, Intravenous
Peripheral Nervous System Diseases
Physiological Effects of Drugs

Nervous System Diseases
Rho(D) Immune Globulin
Pharmacologic Actions
Immunoglobulins
Neuritis

ClinicalTrials.gov processed this record on July 02, 2009