Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy
Condition: Multifocal Motor Neuropathy
MeSH terms: Neuritis
Intervention: Immune Globulin Intravenous (human), 10%; 0.25% human albumin solution (Placebo)
Intervention description: Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific); 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
Intervention MeSH terms: Pharmaceutical Solutions; Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained from the participant 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) (Olney et al., 2003, see Section 15.1
             for the full length publication). Conduction block can be identified by a drop in
             amplitude. Diagnosis can be based on chart records a) Hand grip (finger flexor)
             weakness of Medical Research Council (MRC) grade 4 or less at disease onset or
             appearing prior to screening; b) No upper motor signs c) No bulbar or cranial signs or
             symptoms; d) No clinically identifiable sensory abnormalities

          -  Must be on a stable regimen of IGIV for at least 3 months prior to first study product
             administration

          -  Treatment interval with IGIV of 2 to 5 weeks (+/- 3 days)

          -  Dose of IGIV to be 0.4 to 2.0 g per kg BW and infusion cycle

          -  Participants 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 clinical or electrophysiological evidence of coexisting neuropathy which may
             interfere with outcome assessments, such as diabetic neuropathy, toxic neuropathy, or
             neuropathy due to systemic lupus erythematosus

          -  Treatment with other immunosuppressive agents besides IGIV, which has demonstrated
             efficacy in MMN such as cyclophosphamide during the 3 months prior to enrollment (or
             treatment with Rituximab during the 12 months prior to enrollment). Pre-study
             treatment with mycophenolate mofetil or azathioprine is permitted if the dose has been
             stable for 3 months prior to enrollment.

          -  Cerebrospinal fluid protein > 100 mg/dL (if done as part of a previous evaluation)

          -  Participants positive at enrollment for one or more of the following: Hepatitis B
             surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C (HCV), PCR
             for human immunodeficiency virus (HIV) Type 1

          -  Participants with levels of alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) > 2.5 times the upper limit of normal for the testing
             laboratory

          -  Participants with neutropenia (defined as an absolute neutrophil count
             [ANC]≤1000/mm^3)

          -  Participants with serum creatinine levels greater than 1.5 times the upper limit of
             normal for age and gender

          -  Participants with malignancy other than adequately treated basal cell or squamous cell
             carcinoma of the skin or carcinoma in situ of the cervix

          -  Participants with a history of thrombotic episodes (deep vein thrombosis, myocardial
             infarction, cerebrovascular accident)

          -  Participants 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

          -  Participants with an ongoing history of hypersensitivity or persistent reactions
             (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV
             or human albumin

          -  Participants with immunoglobulin A (IgA) deficiency and known anti IgA antibodies

          -  Participants using another investigational product or device within 30 days prior to
             enrollment

          -  Participants who are unable or unwilling to meet all the requirements of this study

          -  If female, is pregnant or lactating at time of enrollment