Relapsing Multiple SclerosisPhase 2TRIMS ANCT01006941
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
A Phase 2 study testing Trichuris suis ova in people with Relapsing Multiple Sclerosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Trichuris suis ova
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- May 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- 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 12 months
Who cannot join
- 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 mitoxantroneduring the last year
- previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation
- treatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Multiple Sclerosis Center, Rigshospitalet
Copenhagen, Copenhagen, 2100
About this study
The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Trichuris suis ova
- Keywords
- Multiple sclerosis, safety, MRI, immunological, Helminths, Trichuris suis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichuris suis ovaBiological
Also called TSO
2500 ova per dose, orally, every second week, during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Trichuris suis ova | Experimental | Not described Receives: Biological: Trichuris suis ova |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions
Measured: every 3. week. 3 MRI before treatment and 4 MRI during and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Statens Serum Institut, Copenhagen University Hospital, Hvidovre, OvaMed GmbH
- Responsible party
- Principal investigator, Ana Voldsgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Per S Sørensen, Professor, Study director, Rigshospitalet, Danish Multiple Slerosis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006941
- Sponsor's protocol ID
- Rigshospitalet, DMSC
- Acronym
- TRIMS A
- Status last verified
- Nov 2011
- First submitted
- 7 Oct 2009
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Voldsgaard A, Bager P, Garde E, Akeson P, Leffers AM, Madsen CG, Kapel C, Roepstorff A, Thamsborg SM, Melbye M, Siebner H, Sondergaard HB, Sellebjerg F, Sorensen PS. Trichuris suis ova therapy in relapsing multiple sclerosis is safe but without signals of beneficial effect. Mult Scler. 2015 Nov;21(13):1723-9. doi: 10.1177/1352458514568173. Epub 2015 Feb 19.
PubMed 25698173
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
- ClinicalTrials.gov ID
- NCT01006941
- Acronym / sponsor ID
- TRIMS A / Rigshospitalet, DMSC
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Multiple sclerosis, safety, MRI, immunological, Helminths, Trichuris suis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen, Statens Serum Institut, Copenhagen University Hospital, Hvidovre, OvaMed GmbH
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trichuris suis ova | Experimental | Biological: Trichuris suis ova |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- 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 12 months
Key exclusion criteria (12 listed)
- 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 mitoxantroneduring the last year
- previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trichuris suis ovaAlso: TSO2500 ova per dose, orally, every second week, during 12 weeks | Biological | Trichuris suis ova |
Primary outcome
MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions
Time frame: every 3. week. 3 MRI before treatment and 4 MRI during and after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
- Derived from this study: PubMed 25698173Voldsgaard A, Bager P, Garde E, Akeson P, Leffers AM, Madsen CG, Kapel C, Roepstorff A, Thamsborg SM, Melbye M, Siebner H, Sondergaard HB, Sellebjerg F, Sorensen PS. Trichuris suis ova therapy in relapsing multiple sclerosis is safe but without signals of beneficial effect. Mult Scler. 2015 Nov;21(13):1723-9. doi: 10.1177/1352458514568173. Epub 2015 Feb 19.
Related trials for Relapsing Multiple Sclerosis
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per S Sørensen, Professor study director
Rigshospitalet, Danish Multiple Slerosis Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trichuris suis ova in people with Relapsing Multiple Sclerosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions (time frame: every 3. week. 3 MRI before treatment and 4 MRI during and after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01006941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011; AzTrials last refreshed its copy on 4 Nov 2026.