Status:
WITHDRAWN
Immunoregulation by Controlled Parasite Exposure in Multiple Sclerosis.
Lead Sponsor:
University of Nottingham
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The aim of the study is to determine whether controlled infection with a clinically safe number of larvae of hookworm results in an immune response that is protective in relapsing MS.
Detailed Description
Studies have shown that there may be an inverse relationship between infections with worms including hookworms and inflammatory diseases including multiple sclerosis (MS). This has been explained by a...
Eligibility Criteria
Inclusion
- Patients with documented multiple sclerosis relapsing remitting or secondary progressive with relapses, according to McDonald's criteria, and an MRI scan consistent with MS according to Fazekas criteria
- Patients with at least 1 relapse in the last 12 months
- Patients with EDSS score in the range of 0 to 5.5 at the baseline visit
- Patients of both genders, age \>18 years and \< 60 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, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
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.
- 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
- 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 or immunosuppressive drugs within 26 weeks prior to baseline
- Treatment with bone marrow transplantation, total lymphoid irradiation, monoclonal antibodies, 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 :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00630383
Start Date
February 1 2008
End Date
May 1 2008
Last Update
June 14 2012
Active Locations (1)
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1
Nottingham University Hospital NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH