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| Sponsored by: |
Baxter Healthcare Corporation |
| Information provided by: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00666263 |
Purpose
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 (Human), 10% (IGIV, 10%) Drug: Placebo: 0.25% human albumin solution (BUMINATE 25%) |
Phase III |
| ChemIDplus related topics: | Globulin, Immune Immunoglobulins |
| 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: | July 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Sequence 1: Experimental
Stabilization Phase 1 (IGIV, 10%) -> Randomized Treatment / subjects randomized to Sequence 1: cross-over Period 1 (IGIV, 10%) - Stabilization Phase 2 (IGIV, 10%) - cross-over Period 2 (Placebo) -> Stabilization Phase 3 (IGIV, 10%)
|
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Stabilization Phase 1 (12 weeks) with IGIV, 10% (with 3, 4 or 6 intravenous infusions cycles, depending on pre-study treatment) -> Randomized Treatment (36 weeks) / subjects randomized to Sequence 1: cross-over Period 1 (12 weeks) with IGIV, 10%, followed by Stabilization Phase 2 (12 weeks) with IGIV, 10%, followed by cross-over Period 2 (12 weeks) with Placebo -> Stabilization Phase 3 (same treatment as in Stabilization Phase 1)
Drug: Placebo: 0.25% human albumin solution (BUMINATE 25%)
see Intervention Description for Sequence 1 (IGIV,10%)
|
|
Sequence 2: Experimental
Stabilization Phase 1 (IGIV, 10%) -> Randomized Treatment / subjects randomized to Sequence 2: cross-over Period 1 - Stabilization Phase 2 (IGIV, 10%)- cross-over Period 2 (IGIV, 10%) -> Stabilization Phase 3 (IGIV, 10%)
|
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Stabilization Phase 1 (12 weeks) with IGIV, 10% (with 3, 4 or 6 intravenous infusions cycles, depending on pre-study treatment) -> Randomized Treatment (36 weeks) / subjects randomized to Sequence 1: cross-over Period 1 (12 weeks) with IGIV, 10%, followed by Stabilization Phase 2 (12 weeks) with IGIV, 10%, followed by cross-over Period 2 (12 weeks) with Placebo -> Stabilization Phase 3 (same treatment as in Stabilization Phase 1)
Drug: Placebo: 0.25% human albumin solution (BUMINATE 25%)
see Intervention Description for Sequence 2 (IGIV, 10%)
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| USC University Hospital | Not yet recruiting | ||||
| Los Angeles, California, United States, 90033 | |||||
| Contact: Said R Beydoun, MD 323-442-8472 sbeydoun@usc.edu | |||||
| Principal Investigator: Said R Beydoun, MD | |||||
| University of California, San Francisco Medical Center | Not yet recruiting | ||||
| San Francisco, California, United States, 94143 | |||||
| Contact: Jeffrey Ralph, MD 415-353-1994 Jeffrey.Ralph@ucsf.edu | |||||
| Principal Investigator: Jeffrey Ralph, MD | |||||
| United States, Kansas | |||||
| University of Kansas Medical Center | Recruiting | ||||
| Kansas City, Kansas, United States, 66160 | |||||
| Contact: Mazen Dimachkie, MD 913-588-0649 mdimachkie@kumc.edu | |||||
| Principal Investigator: Mazen Dimachkie, MD | |||||
| United States, Kentucky | |||||
| Kentucky Neuroscience Research / University of Louisville | Recruiting | ||||
| Louisville, Kentucky, United States, 40202 | |||||
| Contact: Martin E Brown, MD 502-589-6990 ext 276 martin.brown@louisville.edu | |||||
| Principal Investigator: Martin E Brown, MD | |||||
| United States, Maryland | |||||
| John Hopkins University | Recruiting | ||||
| Baltimore, Maryland, United States, 21287 | |||||
| Contact: David R Cornblath, MD 410-955-2229 dcornbl@jhmi.edu | |||||
| Principal Investigator: David R Cornblath, MD | |||||
| University of Maryland, Department of Neurology | Not yet recruiting | ||||
| Baltimore, Maryland, United States, 21201-1595 | |||||
| Contact: James W Russell, MD 410-706-6689 jrussell@som.umaryland.edu | |||||
| Principal Investigator: James W Russell, MD | |||||
| United States, Massachusetts | |||||
| Brigham and Women´s Hospital | Not yet recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Contact: Anthony Amato, MD 617-732-8081 aamato@partners.org | |||||
| Principal Investigator: Anthony Amato, MD | |||||
| United States, Missouri | |||||
| Washington University School of Medicine, Department of Neurology | Recruiting | ||||
| St. Louis, Missouri, United States, 63110 | |||||
| Contact: Glenn Lopate, MD 314-362-6981 lopateg@neuro.wustl.edu | |||||
| Principal Investigator: Glenn Lopate, MD | |||||
| United States, New York | |||||
| Columbia University | Not yet recruiting | ||||
| New York, New York, United States, 10032 | |||||
| Contact: Louis Weimer, MD 212-305-1516 Lhw1@columbia.edu | |||||
| Principal Investigator: Louis Weimer, MD | |||||
| United States, Ohio | |||||
| The Ohio State University | Recruiting | ||||
| Columbus, Ohio, United States, 43210 | |||||
| Contact: Victoria Lawson, MD 614-293-4973 victoria.lawson@osumc.edu | |||||
| Principal Investigator: Victoria Lawson, MD | |||||
| United States, Oregon | |||||
| Oregon Health & Science University | Not yet recruiting | ||||
| Portland, Oregon, United States, 97239 | |||||
| Contact: Edward J Cupler, MD 503-418-2125 cuplere@ohsu.edu | |||||
| Principal Investigator: Edward J Cupler, MD | |||||
| United States, Texas | |||||
| Baylor College of Medicine | Recruiting | ||||
| Houston, Texas, United States, 77030 | |||||
| Contact: Yadollah Harati, MD 713-798-5694 yharati@bcm.tmc.edu | |||||
| Principal Investigator: Yadollah Harati, MD | |||||
| United States, Utah | |||||
| University of Utah | Not yet recruiting | ||||
| Salt Lake City, Utah, United States, 84132 | |||||
| Contact: Mark Bromberg, MD 801-585-5885 mbromberg@hsc.utah.edu | |||||
| Principal Investigator: Mark Bromberg, MD | |||||
| United States, Virginia | |||||
| University of Virginia, Department of Neurology | Not yet recruiting | ||||
| Charlottesville, Virginia, United States, 22908 | |||||
| Contact: Lawrence H Phillips, MD 434-924-5361 lhp3n@Virginia.edu | |||||
| Principal Investigator: Lawrence H Phillips, MD | |||||
| Canada, Alberta | |||||
| University of Calgary | Not yet recruiting | ||||
| Calgary, Alberta, Canada, T2N 4N1 | |||||
| Contact: Douglas Zochodne, MD 403-220-8831 dzochodn@ucalgary.ca | |||||
| Principal Investigator: Douglas Zochodne, MD | |||||
| Canada, Ontario | |||||
| London Health Sciences Centre | Not yet recruiting | ||||
| London, Ontario, Canada, N6A 5A5 | |||||
| Contact: Angelika Hahn, MD 519-663-3110 Angelika.Hahn@lhsc.on.ca | |||||
| Principal Investigator: Angelika Hahn, MD | |||||
| Queen´s University / Kingston General Hospital | Not yet recruiting | ||||
| Kingston, Ontario, Canada, K7L 3N6 | |||||
| Contact: Michel Melanson, MD 613-549-6666 mm42@post-queensu.ca | |||||
| Principal Investigator: Michel Melanson, MD | |||||
| Canada, Quebec | |||||
| McGill University Health Centre / Montreal General Hospital | Not yet recruiting | ||||
| Montreal, Quebec, Canada | |||||
| Contact: Colin Chalk, MD 514-934-8059 colin.chalk@mcgill.ca | |||||
| Principal Investigator: Colin Chalk, MD | |||||
| Baxter Healthcare Corporation |
| Study Director: | Baxter BioScience Investigator | Baxter Healthcare Corporation |
More Information
| Responsible Party: | Baxter Healthcare Corporation ( Alison Nimchuk, MPH; Clinical Project Manager ) |
| Study ID Numbers: | 160604 |
| First Received: | April 23, 2008 |
| Last Updated: | August 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00666263 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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