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

February 4, 2019 updated by: University of Wisconsin, Madison
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53972
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Therapy with Helminths

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Multiple Sclerosis Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John O Fleming, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-0484, 2007-0390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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