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. MedDRA version: 9.1 Level: LLT Classification code 10065579 Term: Multifocal motor neuropathy
Conditions
Interventions
Trade Name: Vivaglobin
Product Name: Vivaglobin
Pharmaceutical Form: Solution for injection
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: % (W/V) percent weight/volume
Concentration typ
Sponsors
CSL Behring AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the efficacy, safety and convenience of subcutaneous immunoglobulin (Vivaglobin) treatment in MMN patients.;Secondary Objective: ;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. | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed