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Completed

NCT Number: NCT01006941

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

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Key information

Conditions

Relapsing Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Danish Multiple Sclerosis Center, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trichuris suis ova

Biological

2500 ova per dose, orally, every second week, during 12 weeks

Other names: TSO

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen University Hospital, Hvidovre
  • OvaMed GmbH
  • Statens Serum Institut
  • University of Copenhagen

Registry information

Acronym: TRIMS A

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2009
Registry last updated
Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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