E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple Sclerosis, with primary and secondary progressive courses. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
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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 |
The objective is to evaluate the effect on the clinical outcome measures of treatment with NeoRecomorn compared with placebo in patients with progressive Multiple Sclerosis. The primary outcome measure is a composite of maximum gait distance, 9-hole peg test, TRAIL making B. |
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E.2.2 | Secondary objectives of the trial |
Secondary outcome measures include maximum gait distance, 9-hole peg test, TRAIL making B, MS Functional Composite, Expanded Disability Status Score, MR skanning measures of the brain, and safety measures. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age between 19 and 55 years inclusive. Multiple Sclerosis (MS) according to the revised McDonald criteria: either primary progressive MS or secondary progressive MS without relapses during the last one year. MS disease duration of at least two years from onset of disease. Progression of more than 1 point on the EDSS scale during the last 2 years. EDSS (Expanded Disability Status Score) of more than or equal to 4 and less than or equal to 6.5. MRI scan of the brain that fulfills the Barkhof criteria for MS. Written informed consent. |
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E.4 | Principal exclusion criteria |
Pregnancy or period of breastfeeding; missing adequate contraceptive protection for female patients with childbearing potential. Acceptable methods of birth control in this study include: sexually inactive, surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, longacting injectable contraceptive or a double-barrier method (condom or diaphragm with spermicide). Treatment with steroids in the last 30 days Previous treatment with EPO Treatment with interferons, glatiramer acetate or IVIG in the 3 months prior to enrolment Treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension (systolic > 180, diastolic > 110) History of any haematological disorder History of renal insufficiency Any medical psychiatric or other circumstances which impede or restrict the subjects participation in the study in the manner intended Contraindication for MRI (e.g. pace maker, aortic clip or any metal implant)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is the change from baseline to 24 weeks in a composite score of maximum gait distance, 9-hole peg test and TRAIL making B test, comparing the placebo treated group with the NeoRecomorn group. |
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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 | Yes |
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
| Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |