Worms for Immune Regulation of Multiple Sclerosis
Worms for Immune Regulation of Multiple Sclerosis (WIRMS)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Hookworm larvae
Placebo
- Placebo
What it measured
Main measures
The cumulative number of new or enlarging Gd+ lesions at month 9
Month 9
MRI lesions
Other measures (3)
Percentage of cells positive simultaneously for CD4, CD25, foxp3
End of trial
Immune responseCumulative number of newly active lesions (new GD+ T1; new and enlarging T2) at month 9
Month 9
MRI lesionsChange in expanded disability status scale (EDSS) at month 9
Month 9
Disability progression
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
* 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 criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Experimental infection with the hookworm, Necator americanus, is associated with stable gut microbial diversity in human volunteers with relapsing multiple sclerosis.BMC Biol · 2021
Results
Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial.JAMA Neurol · 2020
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History
Started
Dec 2011
Main results due
Jan 2016
Finished
Jan 2016