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

Primary Purpose

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

immune globulin

About this trial

This is an interventional treatment trial for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating focused on measuring demyelinating neuropathy, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004286

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Vermont

1. Study Identification

Unique Protocol Identification Number

NCT00004286

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2000

Overall Recruitment Status

Completed

Study Start Date

February 1996 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Vermont

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Keywords

demyelinating neuropathy, neurologic and psychiatric disorders, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

Double

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

immune globulin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rup Tandan

Organizational Affiliation

University of Vermont

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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