Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS A

Phase 1

• Conditions: Relapsing Multipel Sclerosis; MedDRA version: 12.0Level: LLTClassification code 10028245Term: Multiple sclerosis; MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis; MedDRA version: 12.0Level: LLTClassification code 10053395Term: Progressive multiple sclerosis

• Registration Number: EUCTR2008-007549-29-DK
• Lead Sponsor: Danish Multiple Sclerosis Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-06
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• 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
?EDSS ? 5.5 (expanded disability scale – see Appendix B and C)
?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 6 months or at least 1 documented relapse during the last 24 months with at least one Gadolinium positive lesion on a screening MRI.
?nine or more focal brain lesions on MRI according to the Barkhof criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 mitoxantrone, cyclophosphamide or other intensive immunosupression, total irradiation or any kind of experimental therapy
?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 such as hepatitis B virus, hepatitis C virus, HIV and other infections which the investigator might find relevant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate safety of TSO in the treatment of relapsing Multipel Sclerosis patients;Secondary Objective: ;Primary end point(s): ?Standard safety parameters including adverse events, clinical laboratory tests and vital signs<br>?MRI scans <br>?Relapses<br>