Relapsing Multipel Sclerosis MedDRA version: 12.0 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 12.0 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis MedDRA version: 12.0 Level: LLT Classification code 10053395 Term: Progressive multiple sclerosis
Conditions
Interventions
Product Name: Trichuris suis Ova
Product Code: TSO
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Trichuris suis eggs
Current Sponsor code: Trichuris suis eggs
Other descriptive name: Trich
Sponsors
Danish Multiple Sclerosis Research Center
Eligibility
Sex/Gender
All
Inclusion 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 ? 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ? MRI scans ? Relapses | — |
Countries
Denmark
Outcome results
None listed