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

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ClinicalTrials.gov Identifier: NCT00645749
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : February 6, 2019
National Multiple Sclerosis Society
Information provided by (Responsible Party):
University of Wisconsin, Madison

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).

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Biological: Helminth ova Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple Sclerosis
Study Start Date : July 2008
Actual Primary Completion Date : August 13, 2015
Actual Study Completion Date : August 13, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. MS activity, as judged by the number of new gadolinium-enhancing lesions on serial MRI scans [ Time Frame: Up to 19 months ]
    MS activity will be assessed based on the number of new gadolinium-enhancing lesions on serial MRI scans.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645749

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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
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Principal Investigator: John O Fleming, MD University of Wisconsin, Madison
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00645749    
Other Study ID Numbers: 2012-0484, 2007-0390
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases