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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00645749
First received: March 25, 2008
Last updated: January 16, 2013
Last verified: January 2013
  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: 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:


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: 18
Study Start Date: July 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Helminth ova
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)
Other Name: Therapy with Helminths

Detailed Description:

Phase 1 of the HINT trial was completed with enrollment of 5 subjects. HINT Phase 2 is now closed to enrollment of 15 subjects. Recruitment sites are the UW-Madison and the Marshfield Clinic.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • McDonald Committee (2010) criteria for RRMS (MS) .
  • ambulatory patients with disability scores of EDSS 0.-5.0
  • male or female subjects; ages 18-50
  • 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:

  • patients who are unwilling or unable to give written informed consent or to follow the protocol successfully
  • allergy to Trichuris species
  • treatment with metronidazole (Flagyl) or other medications with anti-helminth effects (IB 5.7)
  • previous or anticipated treatment with FDA-approved or other experimental medications for RRMS
  • previous treatment with immunosuppressive therapy, cytotoxic chemotherapy, or lymphoid irradiation for any reason
  • insulin dependent diabetes mellitus
  • history of HIV-1, HTLV-1, viral hepatitis, or Lyme disease.
  • requirement for chronic, sustained aspirin or non-steroidal anti-inflammatory medications (e.g., use of more than 5-6 days per month for transient symptoms)
  • significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.
  • presence or history of cancer of any type (except successfully treated basal cell or squamous cell carcinoma of skin)
  • history of alcohol or drug abuse in last 12 months; chronic liver or biliary disease; AST or ALT determination greater than two times the upper limit of normal
  • any of the following laboratory abnormalities: serum creatinine > 1.7 mg/DL, white blood count < 3,500/mm3, lymphocyte count < 800/mm3
  • special subjects such as minor children, mentally disabled persons, or prisoners
  • any contraindication to MRI scanning, including significant claustrophobia or sensitivity to gadolinium contrast agent
  • pregnancy and lactation; women of childbearing potential must have a documented negative serum beta HCG pregnancy test at entry and during the study and must be willing to practice adequate birth control for the duration of the study
  • any MS attack or treatment with corticosteroid medication within 30 days of study entry (corticosteroids may be used during the study for MS relapses per the judgment of the treating physician, IB 5.7, IB 6.1.3)
  • immediate household or family contacts who are immunodeficient or immunosuppressed
  • history of parasitism or positive determination ova and parasite stool at screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53972
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):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00645749     History of Changes
Other Study ID Numbers: 2012-0484, 2007-0390
Study First Received: March 25, 2008
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014