Helminth-Induced Immunomodulation Therapy (HINT) in Relapsing-Remitting Multiple Sclerosis

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, July 2008

First Received: March 25, 2008 Last Updated: February 5, 2009 History of Changes

Sponsor:	University of Wisconsin, Madison
Collaborator:	National Multiple Sclerosis Society
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00645749

Purpose

The hypothesis of this study is that helminth-induced immunomodulation therapy (HINT) will be safe and effective when administered orally in patients with relapsing-remitting multiple sclerosis (RRMS).

Condition	Intervention
Multiple Sclerosis	Biological: Helminth ova

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Helminth-Induced Immunomodulation Therapy (HINT) in Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

MS activity, as judged by the number of new gadolinium-enhancing lesions on serial MRI scans. [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental Subjects serving as their own controls (baseline - end-of-treatment) will receive a dose of 2,500 ova, in liquid form, every 2 weeks	Biological: Helminth ova 2500 ova per dose (liquid form)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosed with RRMS within the last two years
have had at least two clinical attacks in the two years prior to enrollment
unwilling to be treated with conventional, FDA-approved parenteral medications for RRMS

Exclusion Criteria:

previous treatment with FDA-approved medications for RRMS
insulin dependent diabetes
Lyme disease
pregnancy
require use of aspirin or chronic non-steroidal anti-inflammatory medications
history of parasitism or positive determination of ova and/or parasite stool at screening
history of HIV infection
history of alcohol/drug abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645749

Contacts

Contact: John O Fleming, MD	608-263-2593	fleming@neurology.wisc.edu
Contact: Andrea L Maser, MS	608-265-6544	alm@clinicaltrials.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics	Recruiting
Madison, Wisconsin, United States, 53972
Contact: Andrea L Maser, MS 608-265-6544 alm@clinicaltrials.wisc.edu
Principal Investigator: John O Fleming, MD

Sponsors and Collaborators

University of Wisconsin, Madison

National Multiple Sclerosis Society

Investigators

Principal Investigator:

John O Fleming, MD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of WIsconsin ( John O. Fleming, MD )
Study ID Numbers:	2007-0390
Study First Received:	March 25, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00645749 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 05, 2009