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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00666263 |
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 |
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
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Drug: Immune Globulin Intravenous, 10%
Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific)
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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
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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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Baxter BioScience Investigator | Baxter Healthcare Corporation |
Responsible Party: | Baxter Healthcare Corporation ( Alison Nimchuk, MPH; Clinical Project Manager ) |
Study ID Numbers: | 160604 |
Study First Received: | April 23, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00666263 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Antibodies Immunologic Factors Neuromuscular Diseases Immunoglobulins, Intravenous Peripheral Nervous System Diseases |
Rho(D) Immune Globulin Motor Neuropathy Immunoglobulins Neuritis |
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 |