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

Phase 2

Completed

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Biological: Trichuris suis ova

• Registration Number: NCT01006941
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Study Start: 2010-05
• Primary Completion: 2011-01
• Study Completion: 2011-09
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-09
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trichuris suis ova	Trichuris suis ova	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Danish Multiple Sclerosis Center, Rigshospitalet; 🇩🇰 Copenhagen, Denmark