Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety
Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Trichuris suis ova
- Trichuris suis eggs
What it measured
Main measures
MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions
every 3. week. 3 MRI before treatment and 4 MRI during and after treatment
MRI lesions Standard safety parameters including adverse events, clinical laboratory tests and vital signs
Safety
Who could take part
Relapsing and progressive · 19 to 55
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
May 2010
Main results due
Jan 2011
Finished
Sept 2011