E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with multifocal motor neuropathy, who are treated successful with IVIG and had a stable IVIG treatment schedule for at least 12 weeks prior to screening. |
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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 | 10065579 |
E.1.2 | Term | Multifocal motor neuropathy |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to assess the efficacy, safety and convenience of subcutaneous immunoglobulin (Vivaglobin) treatment in MMN patients. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Males and females age > 18 years 2. Patients with documented clinical diagnosis and electrophysiological evidence of MMN 3. Patients who previously responded to IVIG and are on stable treatment with IVIG for at least 12 weeks prior screening 4. Patients treated with the equivalent of >= 0.4 g/kg body weight (bw) IVIG per month 5. Women of childbearing potential must use a medically approved method of contraception and must have a negative urine pregnancy test at screening 6. Provision of informed consent by patient |
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E.4 | Principal exclusion criteria |
1. ASAT or ALAT concentration > 2.5 times the UNL 2. Creatinine concentration > 1.5 times the UNL 3. Known allergic reactions to blood products 4. Any skin disease interfering with the assessment of injection site reactions 5. Any other medical condition, which in the opinion of the investigator may interfere with successful completion of the protocol 6. Any condition likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial 7. Participation in a study with an investigational drug within three months prior to enrolment 8. Patients treated with the equivalent of > 2.0 g/kg bw IVIG per month |
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E.5 End points |
E.5.1 | Primary end point(s) |
Muscle strength will be assessed on standardized 40 muscles or muscle groups of the upper and lower limbs (i.e. to be determined on a maximum of 20 muscles or muscle groups of left and right body part respectively) as indicated in Appendix 5 of the protocol. Muscle strength will be measured using a modified Medical Research Council (MRC) Scale at Week 24 in comparison to baseline MRC. |
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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 | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |