Clinical trial NCT01006941: Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
Official title: Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing Multiple Sclerosis
Keywords: Multiple sclerosis
safety
MRI
immunological
Helminths
Trichuris suis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Statens Serum Institut
name: Copenhagen University Hospital, Hvidovre
name: OvaMed GmbH
First posted: 2009-11-03
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions
timeFrame: every 3. week. 3 MRI before treatment and 4 MRI during and after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Multiple Sclerosis Center, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Danish Multiple Slerosis Research Center
name: Per S Sørensen, Professor
role: STUDY_DIRECTOR
References:
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.