CompletedPhase 3

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

United States50 participantsStarted 2008-08-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 d…

What they're measuring

Grip Strength in the More Affected Hand

Timeframe: Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit

Mean Relative Change in Grip Strength in the More Affected Hand

Timeframe: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs

Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy's Neurological Disability Score (GNDS)

Timeframe: Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)

Rate of Temporally Associated Adverse Events (AEs) Per Infusion

Timeframe: Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)

The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason

Trial details

NCT IDNCT00666263

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-08-11

Results submitted2012-10-19

View on ClinicalTrials.gov More Multifocal Motor Neuropathy trials