Helminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple Sclerosis

This study is currently recruiting participants.

Verified August 2010 by University of Wisconsin, Madison

First Received on March 25, 2008. Last Updated on August 10, 2010 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
Relapsing Remitting Multiple Sclerosis	Biological: Helminth ova

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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
Experimental: Treatment 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)

Detailed Description:

Phase 1 of the HINT trial was completed with enrollment of 5 subjects. HINT Phase 2 is now open to enrollment of 20 subjects. Recruitment sites are the UW-Madison and the Marshfield Clinic.

Eligibility

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

Criteria

Inclusion Criteria:

McDonald Committee (2005) criteria for RRMS (MS) .
ambulatory patients with disability scores of EDSS 0.-5.0
male or female subjects; ages 18-45
diagnosis within three years of study entry, based on either a) two or more clinical attacks in the three years prior to entry or b) one attack within three years of entry, coupled with MRI evidence of dissemination in space and time by strict application of McDonald Committee MRI criteria
active MRI at entry, as evidenced by at least one gd+ enhancing lesion during screening
explicit refusal to be treated with conventional disease-modifying medications (DMT) for RRMS, after full discussion of the potential benefits and risks of these agents and after review of the National Multiple Sclerosis Advisory Statement DMT.
ability to provide written informed consent

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 by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fleming JO, Isaak A, Lee JE, Luzzio CC, Carrithers MD, Cook TD, Field AS, Boland J, Fabry Z. Probiotic helminth administration in relapsing-remitting multiple sclerosis: a phase 1 study. Mult Scler. 2011 Jun;17(6):743-54. Epub 2011 Mar 3.

Responsible Party:	John O. Fleming, MD, University of WIsconsin
ClinicalTrials.gov Identifier:	NCT00645749 History of Changes
Other Study ID Numbers:	2007-0390
Study First Received:	March 25, 2008
Last Updated:	August 10, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012