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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01006941

Acronym

TRIMS A

Enrollment

Registered

2009-11-03

Start date

2010-05-31

Completion date

2011-09-30

Last updated

2011-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Keywords

Multiple sclerosis, safety, MRI, immunological, Helminths, Trichuris suis

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.

Interventions

BIOLOGICALTrichuris suis ova

2500 ova per dose, orally, every second week, during 12 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions	every 3. week. 3 MRI before treatment and 4 MRI during and after treatment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026