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

October 7, 2009
November 9, 2011
May 2010
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01006941 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
Biological: Trichuris suis ova
2500 ova per dose, orally, every second week, during 12 weeks
Other Name: TSO
Experimental: Trichuris suis ova
Intervention: Biological: Trichuris suis ova
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
19 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01006941
Rigshospitalet, DMSC
Yes
Ana Voldsgaard, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • University of Copenhagen
  • Statens Serum Institut
  • Copenhagen University Hospital, Hvidovre
  • OvaMed GmbH
Study Director: Per S Sørensen, Professor Rigshospitalet, Danish Multiple Slerosis Research Center
Rigshospitalet, Denmark
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP