Table 1 Eligibility criteria

Key inclusion criteria

Diagnosis of RRMS in accordance to the revised McDonald criteria (2005) or CIS

Aged 18 to 65 years, inclusive

Expanded Disability Status Scale (EDSS) at screening score ≤4.0

Ability to provide written informed consent

Disease activity on brain defined by:

(A) ≥1 gadolinium enhancing lesion on screening MRI or another MRI performed in the 12 months prior to screening OR

(B) ≥1 new T2 lesion on screening MRI or on another MRI performed in the 12 months prior to screening in comparison to an earlier MRI performed in the previous 36 months OR

(C) ≥1 enlarging T2 lesion on screening MRI or on another MRI performed in the 12 months before screening in comparison to an earlier MRI performed in the previous 36 months

Adequate birth control by a contraception method with a PEARL-index <1 in women of childbearing potential

Contraindication or intolerance for established standard immunomodulatory treatments with interferon-β or glatiramer acetate

Information about established standard immunomodulatory treatments for MS by an independent neurologist and explicit decision of the patient against these treatment

Stable neurological state at study inclusion without any signs of a relapse and without steriod therapy in the last 30 days

Key exclusion criteria

Any disease other than MS that may better explain the symptoms and signs

Any other immunomodulatory or immunosuppressive treatment, for example, interferon-β, mitoxantrone, glatiramer acetate, natalizumab within the preceding three months

Any significant uncontrolled disease, such as neoplasia, relevant liver disorder, active hepatitis B or C, and reduced liver function

Relevant laboratory findings:

 • aspartate aminotransferase/alanine aminotransferase (ASAT/ALAT) >3 times of reference value

 • bilirubine >1.5 mg/dl

 • hemoglobin <8.5 g/dl

 • white blood count <2.5/nl

 • thrombocytes <125/nl

 • creatinine-clearance according to Cockroft-Gault-formula <110 ml/min (male) and <95 ml/min (female)

Any severe medical conditions or additional autoimmune disease which requires a immunosuppressive or immunomodulatory treatment

Any psychiatric or other condition that impedes the ability to provide informed consent or patient’s compliance

Refusal of transmission of personal data

Inability to complete an MRI scan

Relapse within 30 days of trial entry

Known allergies against components of TSO or placebo

Participation in any interventional clinical trial in the last three months or during the participant in TRIOMS

Pregnancy or breast feeding

Concomitant medication with antihelminthic therapy

History of small intestinal resection