Status:
COMPLETED
Worms for Immune Regulation of Multiple Sclerosis
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
National Multiple Sclerosis Society
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether people with MS who are exposed to a small number of hookworms will have less inflammation and less MS disease activity.
Detailed Description
There is evidence that certain parasitic infections may protect against autoimmune or inflammatory diseases, including multiple sclerosis (MS), asthma and type1 diabetes. The 'hygiene hypothesis' post...
Eligibility Criteria
Inclusion
- Relapsing remitting MS (RRMS) (McDonald criteria) and secondary MS with super imposing relapse on condition that they fulfil the next conditions, MRI scan consistent with MS by Barkhof or Fazekas criteria
- Patients with at least 1 relapse in the last 12 months or 2 in the last 24 months;
- Patients with Expanded disability status scale (EDSS) score in the range of 0 to 5.5 at the screening and week 0 visit
- Patients of both genders, age \>18 years and \< 65 years
- Women of child bearing potential, (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study.
- Be able and willing to comply with study visits and procedures per protocol.
- Understand and sign consent form at the screening
Exclusion
- No populations at risk of severe illness or death will be included in this study
- Life expectancy \< 6 months.
- Patient is \< 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.
- Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
- Patients with severe and/or uncontrolled medical condition.
- Pregnancy, lactation or intention to become pregnant during the course of the study (please also see above under inclusion criterion 5)
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- Anaemia (Hb \<10 g/dL for females, \<11 g/dL for males)
- Prior or present evidence of parasitic infection; prior treatment with anti-helminthic drugs in the last 6 years.
- Patient with serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol
- History of poor compliance or history of drug/alcohol abuse, or excessive alcohol consumption that would interfere with the ability to comply with the study protocol,
- Severe asthma, allergy, other autoimmune disease or any condition that the physician judges could be detrimental to subjects participating in this study; including deviations deemed clinically important from normal clinical laboratory
- Previous treatment
- Treatment with interferon or glatiramer acetate within 8 weeks prior to baseline or immunosuppressive drugs within 12 weeks prior to baseline
- Treatment with bone marrow transplantation, total lymphoid irradiation, monoclonal antibodies (other than natalizumab, umbilical cord stem cells, AIMSPRO at any time prior to baseline
- Treatment with corticosteroids or ACTH within 4 weeks prior to baseline
- Treatment with any investigational agent within 12 weeks prior to baseline
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01470521
Start Date
December 1 2011
End Date
January 1 2016
Last Update
January 29 2016
Active Locations (1)
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1
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH