ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy

This study is currently recruiting participants.
Study NCT00666263.   Last updated on November 27, 2008.   Information provided by Baxter Healthcare Corporation

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy
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
Brief 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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary Outcome Measure  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 ]
Secondary Outcome Measure 
Condition  Multifocal Motor Neuropathy
Intervention  Drug: Immune Globulin Intravenous, 10%
Drug: Immune Globulin Intravenous, 10% or Placebo (0.25% human albumin solution)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  July 2008
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00666263
Organization ID 160604
Secondary IDs ††
Study Sponsor  Baxter Healthcare Corporation
Collaborators ††
Investigators 
Study Director:     Baxter BioScience Investigator     Baxter Healthcare Corporation    
Information Provided By Baxter Healthcare Corporation
Verification Date November 2008
First Received Date  April 23, 2008
Last Updated Date November 27, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers