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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2008-005008-24-GB |
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Date of registration:
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19/05/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Worms for immune regulation of multiple sclerosis - MS and hookworm
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Scientific title:
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Worms for immune regulation of multiple sclerosis - MS and hookworm |
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Date of first enrolment:
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07/07/2011 |
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Target sample size:
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72 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005008-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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 < 60 years
5) 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.
6) Be able and willing to comply with study visits and procedures per protocol.
7) Understand and sign consent form at the screening
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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 system disorders
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Intervention(s)
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Product Name: Necator americanus
Pharmaceutical Form: Spot-on solution
Other descriptive name: Live Necator americanus larvae
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 25 -
Pharmaceutical form of the placebo: Spot-on solution
Route of administration of the placebo: Topical use (Noncurrent)
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Primary Outcome(s)
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Primary end point(s): The primary endpoint is the cumulative number of new or enlarging Gd+ lesions at month 9
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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.
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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.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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