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

Primary Purpose

Relapsing Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Trichuris suis ova
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring Multiple sclerosis, safety, MRI, immunological, Helminths, Trichuris suis

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danish Multiple Sclerosis Center, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trichuris suis ova

Arm Description

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
October 7, 2009
Last Updated
November 9, 2011
Sponsor
Rigshospitalet, Denmark
Collaborators
University of Copenhagen, Statens Serum Institut, Copenhagen University Hospital, Hvidovre, OvaMed GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01006941
Brief Title
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
Acronym
TRIMS A
Official Title
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
University of Copenhagen, Statens Serum Institut, Copenhagen University Hospital, Hvidovre, OvaMed GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis
Keywords
Multiple sclerosis, safety, MRI, immunological, Helminths, Trichuris suis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trichuris suis ova
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Trichuris suis ova
Other Intervention Name(s)
TSO
Intervention Description
2500 ova per dose, orally, every second week, during 12 weeks
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per S Sørensen, Professor
Organizational Affiliation
Rigshospitalet, Danish Multiple Slerosis Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Danish Multiple Sclerosis Center, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25698173
Citation
Voldsgaard A, Bager P, Garde E, Akeson P, Leffers AM, Madsen CG, Kapel C, Roepstorff A, Thamsborg SM, Melbye M, Siebner H, Sondergaard HB, Sellebjerg F, Sorensen PS. Trichuris suis ova therapy in relapsing multiple sclerosis is safe but without signals of beneficial effect. Mult Scler. 2015 Nov;21(13):1723-9. doi: 10.1177/1352458514568173. Epub 2015 Feb 19.
Results Reference
derived

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

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