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

Tracking Information

First Received Date ^ICMJE

March 25, 2008

Last Updated Date

February 5, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00645749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Biological: Helminth ova

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00645749

Responsible Party

John O. Fleming, MD, University of WIsconsin

Study ID Numbers ^ICMJE

2007-0390

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

National Multiple Sclerosis Society

Investigators ^ICMJE

Principal Investigator:

John O Fleming, MD

University of Wisconsin, Madison

Information Provided By

University of Wisconsin, Madison

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP