Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01006941
• Date of registration: 07/10/2009
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study TRIMS A
• Scientific title: Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
• Date of first enrolment: May 2010
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01006941
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Denmark

Contacts

• Name: Per S Sørensen, Professor
• Affiliation: Rigshospitalet, Danish Multiple Slerosis Research Center

Key inclusion & exclusion 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

- 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

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 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

- 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



Age minimum: 19 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Biological: Trichuris suis ova

Primary Outcome(s)

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]

Secondary ID(s)

Rigshospitalet, DMSC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Danish Research Centre for Magnetic Resonance,Copenhagen University Hospital

Faculty of LIFE Sciences, University of Copenhagen

OvaMed GmbH

Statens Serum Institut