E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing Multiple Sclerosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063400 |
E.1.2 | Term | Secondary progressive multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
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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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the cumulative number of new or enlarging Gd+ lesions at month 9 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is the last visit of the last patient enrolled in the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 28 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 28 |