Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome (TRIOMS)
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ClinicalTrials.gov Identifier: NCT01413243 |
Recruitment Status :
Terminated
First Posted : August 10, 2011
Last Update Posted : May 6, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Trichuris suis ova | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome - A Monocentric, Prospective, Randomized, Double-blind and Placebo-controlled Phase 2 Trial |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | June 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Drug: Trichuris suis ova
Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months
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Drug: Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks
Other Name: TSO |
Placebo Comparator: Placebo
Drug: Placebo, fluid every 2 weeks
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Drug: Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks
Other Name: TSO |
- Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ]
- reduction NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 12 month of treatment ]
- Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ]
- Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ]
- Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite), [ Time Frame: after 12 months of treatment ]
- Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of the study and have every 3 month planed visits. ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- active Recurrent remittent Multiple Scleosis or Clinically isolated Syndrome
- inefficacy or intolerance for a therapy with Interferon-beta
- age 18 - 65
- EDSS <4
Exclusion Criteria:
- secondary or primary chronic progressive Multiple Sclerosis
- Immunomodulatoric or immunosuppressive therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413243
Germany | |
Charité - Universitätsmedizin Berlin, Department of Neurology | |
Berlin, Germany, 10117 |
Principal Investigator: | Berit Rosche, M.D. | Charité-University | |
Study Chair: | Friedemann Paul, M.D. | Charité - University, NeuroCure Clinical Research Center |
Responsible Party: | Berit Rosche, Dr. med., Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT01413243 |
Other Study ID Numbers: |
TRIOMS-01 |
First Posted: | August 10, 2011 Key Record Dates |
Last Update Posted: | May 6, 2016 |
Last Verified: | May 2016 |
Multipe sclerosis, Trichuris suis ova |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |