NCT01006941

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2009

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

October 7, 2009

Last Update Submit

November 9, 2011

Conditions

Relapsing Multiple Sclerosis

Keywords

Multiple sclerosissafetyMRIimmunologicalHelminthsTrichuris suis

Outcome Measures

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

    every 3. week. 3 MRI before treatment and 4 MRI during and after treatment

Study Arms (1)

Trichuris suis ova

EXPERIMENTAL
Biological: Trichuris suis ova

Interventions

Trichuris suis ovaBIOLOGICAL

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

Also known as: TSO
Trichuris suis ova

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Multiple Sclerosis Center, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25698173DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Per S Sørensen, Professor

    Rigshospitalet, Danish Multiple Slerosis Research Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 7, 2009

First Posted

November 3, 2009

Study Start

May 1, 2010

Primary Completion

January 1, 2011

Study Completion

September 1, 2011

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

DK(1)