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

NCT00645749 | Completed Phase 1 DMC

• 1 other identifier: 2012-0484, 2007-0390
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• MS activity, as judged by the number of new gadolinium-enhancing lesions on serial MRI scans

  MS activity will be assessed based on the number of new gadolinium-enhancing lesions on serial MRI scans.

  Up to 19 months

Study Arms (1)

Helminth ova

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

Biological: Helminth ova

Interventions

Helminth ova BIOLOGICAL

2500 ova per dose (liquid form)

Also known as: Therapy with Helminths

Helminth ova

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53972, United States

Location

Related Publications (2)

• Fleming J, Hernandez G, Hartman L, Maksimovic J, Nace S, Lawler B, Risa T, Cook T, Agni R, Reichelderfer M, Luzzio C, Rolak L, Field A, Fabry Z. Safety and efficacy of helminth treatment in relapsing-remitting multiple sclerosis: Results of the HINT 2 clinical trial. Mult Scler. 2019 Jan;25(1):81-91. doi: 10.1177/1352458517736377. Epub 2017 Oct 24.

  PMID: 29064315 RESULT

• 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. doi: 10.1177/1352458511398054. Epub 2011 Mar 3.

  PMID: 21372112 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Therapy with Helminths

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• John O Fleming, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: July 1, 2008
• Primary Completion: August 13, 2015
• Study Completion: August 13, 2015
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)