Relapsing Multiple Sclerosis MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous s
Conditions
Interventions
Product Name: Necator americanus
Pharmaceutical Form: Spot-on solution
Other descriptive name: Live Necator americanus larvae
Concentration unit: U unit
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) Relapsing remitting MS (RRMS) (McDonald criteria), MRI scan consistent with MS by Barkhof or Fazekas criteria 2) Patients with at least 1 relapse in the last 12 months or 2 in the last 24 months; 3) Patients with Expanded disability status scale (EDSS) score in the range of 0 to 5.5 at the screening and w0 visit 4) Patients of both genders, age >18 years and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 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 • 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 8 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Whether controlled parasitic infection with N. americanus (25 larvae per patient) reduces the cumulative number of gadolinium enhancing (Gd+) lesions in MS at month 9 in comparison to baseline and placebo.;Primary end point(s): The primary endpoint is the cumulative number of new or enlarging Gd+ lesions at month 9; Secondary Objective: Whether controlled parasitic infection with N. americanus (25 larvae per patient) induces an increase in foxp3 positive (CD4+Cd25high) T cells (Treg) in people with MS in comparison to baseline and placebo. Whether controlled parasitic infection with N. americanus (25 larvae per patient) reduces relapses and disability in MS patients compared with placebo. | — |
Countries
United Kingdom
Outcome results
None listed