Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study (TRIMS A)

November 9, 2011 updated by: Ana Voldsgaard, Rigshospitalet, Denmark
The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • Danish Multiple Sclerosis Center, Rigshospitalet

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

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 19 and 55 years
  • relapsing course of multiple sclerosis (relapsing-remitting or secondary progressive MS with relapses
  • duration of the disease of at least 1 year
  • no disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months
  • at least 2 documented relapses during the last 24 months with the last relapse within the last 12 months

Exclusion Criteria:

  • pregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients
  • relapse in the last month prior enrolment
  • treatment with steroids in the last 30 days
  • previous treatment with mitoxantroneduring the last year
  • previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation
  • treatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment
  • cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension
  • diabetes mellitus and other autoimmune diseases
  • history of renal insufficiency
  • stay in tropical areas during the last 3 months
  • eosinophilia in the blood (> 0,45 billion/l)
  • concurrent systemic infections

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trichuris suis ova
Biological: Trichuris suis ova
2500 ova per dose, orally, every second week, during 12 weeks
Other Names:
  • TSO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions
Time Frame: every 3. week. 3 MRI before treatment and 4 MRI during and after treatment
every 3. week. 3 MRI before treatment and 4 MRI during and after treatment

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen
Statens Serum Institut
Copenhagen University Hospital, Hvidovre
OvaMed GmbH

Investigators

  • Study Director: Per S Sørensen, Professor, Rigshospitalet, Danish Multiple Slerosis Research Center

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

May 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (ESTIMATE)

November 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rigshospitalet, DMSC

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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