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

Rigshospitalet

Status and phase

Completed

Phase 2

Conditions

Relapsing Multiple Sclerosis

Treatments

Biological: Trichuris suis ova

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01006941

Rigshospitalet, DMSC

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

19 to 55 years old

Volunteers

No 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