Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
NCT ID: NCT01006941
Last Updated: 2011-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2010-05-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trichuris suis ova
Trichuris suis ova
2500 ova per dose, orally, every second week, during 12 weeks
Interventions
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Trichuris suis ova
2500 ova per dose, orally, every second week, during 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
55 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Statens Serum Institut
OTHER
Copenhagen University Hospital, Hvidovre
OTHER
OvaMed GmbH
INDUSTRY
Rigshospitalet, Denmark
OTHER
Responsible Party
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Ana Voldsgaard
MD
Principal Investigators
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Per S Sørensen, Professor
Role: STUDY_DIRECTOR
Rigshospitalet, Danish Multiple Slerosis Research Center
Locations
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Danish Multiple Sclerosis Center, Rigshospitalet
Copenhagen, Copenhagen, Denmark
Countries
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References
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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.
Other Identifiers
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Rigshospitalet, DMSC
Identifier Type: -
Identifier Source: org_study_id