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

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Statens Serum Institut
Copenhagen University Hospital, Hvidovre
OvaMed GmbH
Information provided by (Responsible Party):
Ana Voldsgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01006941
First received: October 7, 2009
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Relapsing Multiple Sclerosis
Biological: Trichuris suis ova
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trichuris suis ova Biological: Trichuris suis ova
2500 ova per dose, orally, every second week, during 12 weeks
Other Name: TSO

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006941

Locations
Denmark
Danish Multiple Sclerosis Center, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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
  More Information

No publications provided

Responsible Party: Ana Voldsgaard, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01006941     History of Changes
Other Study ID Numbers: Rigshospitalet, DMSC
Study First Received: October 7, 2009
Last Updated: November 9, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Multiple sclerosis
safety
MRI
immunological
Helminths
Trichuris suis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014