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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Vermont |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004286 |
OBJECTIVES:
I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.
Condition | Intervention | Phase |
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
Drug: immune globulin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study |
Estimated Enrollment: | 120 |
Study Start Date: | February 1996 |
Estimated Study Completion Date: | November 1999 |
PROTOCOL OUTLINE: This is a double blind, randomized, controlled study. Patients receive either intravenous human immune globulin (IVIG) or placebo infused at a rate of 40 mL/hr, increasing every 30 min to a maximum of 100 mL/hr daily over 6 to 8 hours for 2 days. On day 2, infusions of IVIG or placebo are delivered at the highest dose tolerated on day 1.
On day 21, patients receive another IVIG or placebo infusion. Following day 42, patients may choose to continue infusions of IVIG every 21 days for 2 doses.
Patients not receiving additional treatment are released from study. Patients are evaluated on days 10, 21, and 43.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Progressive or relapsing disease or chronic stable course with elevated cerebrospinal fluid protein with normal cell counts Acquired demyelination on electrophysiologic studies Segmental demyelination on nerve histology
--Patient Characteristics--
Study ID Numbers: | 199/11713, UVT-535 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004286 History of Changes |
Health Authority: | United States: Federal Government |
demyelinating neuropathy neurologic and psychiatric disorders rare disease |
Autoimmune Diseases Demyelinating Diseases Immunologic Factors Polyradiculoneuropathy Rare Diseases Polyneuropathies Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
Antibodies Neuromuscular Diseases Mental Disorders Peripheral Nervous System Diseases Autoimmune Diseases of the Nervous System Immunoglobulins |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Immunologic Factors Polyradiculoneuropathy Physiological Effects of Drugs Nervous System Diseases Polyneuropathies |
Pharmacologic Actions Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Antibodies Neuromuscular Diseases Peripheral Nervous System Diseases Autoimmune Diseases of the Nervous System Immunoglobulins |