Trichuris suis Oozyten (TSO®) in remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS)

Trichuris suis Oozyten (TSO®) in remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS) - TRIOMS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015319-41-DE

Enrollment

Registered

2011-02-04

Start date

2011-11-03

Completion date

Unknown

Last updated

2021-06-14

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

Conditions

remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS)

Interventions

Product Name: TSO Product Code: TSO Pharmaceutical Form: Oral suspension INN or Proposed INN: Trichuris suis ova (eggs), embryonated, viable Concentration unit: Other Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and female patients between 18 and 65 years - Diagnosis of CIS oder RRMS - Informed Consent - Refusal of standard therapie - EDSS = 4,0 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Patients which receive or have received in the last 3 months a therapy with IFN-ß, Mitoxantron, Copaxone, Natalizumab or another immunsupressive or immunmodulatory treatment - Patients with clinically relevant liver disorder oder insufficiency - Patients with with clinically relevant liver, kidney or bone marrow disorder (see definition in protocol) - pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the efficacy of TSO® in MS and CIS patients, measured as number of new T2 lesions in cMRI after a 12 months treatment - compared to placebo. ;Secondary Objective: To test the efficacy of TSO® in MS and CIS patients, measured as - Volume of new T2 lesions - Number and volume of T1-GD lesions - Brainatrophy - Number of relapses - EDSS (Expanded Disability Status Scale) - MSFC (Multiple Sclerosis Functional Composite) ;Primary end point(s): Number of new t2 lesions in cMRI;Timepoint(s) of evaluation of this end point: Screening and after 3,6,9 months	—

Measure

Time frame

Main Objective: To test the efficacy of TSO® in MS and CIS patients, measured as number of new T2 lesions in cMRI after a 12 months treatment - compared to placebo. ;Secondary Objective: To test the efficacy of TSO® in MS and CIS patients, measured as - Volume of new T2 lesions - Number and volume of T1-GD lesions - Brainatrophy - Number of relapses - EDSS (Expanded Disability Status Scale) - MSFC (Multiple Sclerosis Functional Composite) ;Primary end point(s): Number of new t2 lesions in cMRI;Timepoint(s) of evaluation of this end point: Screening and after 3,6,9 months

—

Secondary

Measure	Time frame
Secondary end point(s): Volume of new T2 lesions - Number and volume of T1-GD lesions - Brainatrophy - Number of relapses - EDSS (Expanded Disability Status Scale) - MSFC (Multiple Sclerosis Functional Composite) ;Timepoint(s) of evaluation of this end point: Screening and after 3,6,9, 12months	—

Countries

Germany

Contacts

Public ContactNCRC

Charité - Universitätsmedizin Berlin

friedemann.paul@charite.de004930450560284

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026