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

University of Wisconsin (UW)

Status and phase

Completed

Phase 1

Conditions

Relapsing Remitting Multiple Sclerosis

Treatments

Biological: Helminth ova

Study type

Interventional

Funder types

Other

Identifiers

NCT00645749

2012-0484, 2007-0390

Details and patient eligibility

About

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).

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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