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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

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Trial Conditions
  • Multifocal Motor Neuropathy
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Baxter BioScience Investigator
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • Immune Globulin Intravenous, 10%
  • Immune Globulin Intravenous, 10% or Placebo (0.25% human albumin solution)
Physician Researcher

Investigator Name:

  • Baxter BioScience Investigator

Other Information

Sponsor: Baxter Healthcare Corporation
Phase: Phase 3
Trial ID: NCT00666263
Volunteers:  Not Accepting Healthy Volunteers

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