Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study - Full Text View

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

This study has been completed.

First Received on October 7, 2009. Last Updated on November 9, 2011 History of Changes

Sponsor:	Rigshospitalet, Denmark
Collaborators:	Faculty of LIFE Sciences, University of Copenhagen Statens Serum Institut Danish Research Centre for Magnetic Resonance,Copenhagen University Hospital OvaMed GmbH
Information provided by (Responsible Party):	Ana Voldsgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT01006941

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 II

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:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

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

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

Faculty of LIFE Sciences, University of Copenhagen

Statens Serum Institut

Danish Research Centre for Magnetic Resonance,Copenhagen University Hospital

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
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012