Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy

This study has been completed.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Vermont
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004286

Purpose

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
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Drug: immune globulin	Phase III

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	120
Study Start Date:	February 1996
Estimated Study Completion Date:	November 1999

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Chronic inflammatory demyelinating polyneuropathy (CIDP) characterized by:

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--

Not pregnant No significant medical disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004286

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Vermont

Investigators

Study Chair:

Rup Tandan

University of Vermont

More Information

Study ID Numbers:	199/11713, UVT-535
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004286
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

demyelinating neuropathy
neurologic and psychiatric disorders
rare disease

Study placed in the following topic categories:

Autoimmune Diseases
Demyelinating Diseases
Polyradiculoneuropathy
Rare Diseases
Polyneuropathies
Demyelinating diseases
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Antibodies
Neuromuscular Diseases
Mental Disorders
Peripheral Nervous System Diseases
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009