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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.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2007-000710-37-IT
Date of registration: 12/02/2008
Prospective Registration: No
Primary sponsor: CSL Behring AG
Public title: A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND
Scientific title: A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND
Date of first enrolment: 04/10/2007
Target sample size: 10
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000710-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Germany Italy United Kingdom
Contacts
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Affiliation: 
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Key inclusion & exclusion criteria
Inclusion criteria:
· Males and females age > 18 years · Patients with documented clinical diagnosis and electrophysiological evidence of MMN · Patients who previously responded to IVIG and are on stable tratment with IVIG for at least 12 weeks prior screening · Patients trated with the equivalent of >=0.4 g/kg body weight (bw) IVIG per month · Women of childbearing potential must use a medically approved method of contraceprion and must have a negative urine pregnancy test at screening · 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:
· ASAT or ALAT concentration > 2.5 times the UNL · creatinine concentration > 1.5 times the UNL · known allergic reactions to blood products · any skin disease interfering with the assessment of injection site reactions · any other medical condition, which in the opinion of the investigator may interfere with successful completion of the protocol · any condition likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial · participation in a study with an investigational drug within three months prior to enrolment · patients treated with the equivalent of > 2.0 g/kg bw IVIG per month


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN.
MedDRA version: 9.1 Level: LLT Classification code 10036105 Term: Polyneuropathy
Intervention(s)

Trade Name: Vivaglobin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm.
Current Sponsor code: CE1200
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 2000-

Primary Outcome(s)
Main Objective: The objective of this study is to assess the efficacy, safety , and convenience of subcutaneous immunoglobulin (Vivaglobin) treatment in MMN patients.
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.
Secondary Objective: n.a.
Secondary Outcome(s)
Secondary ID(s)
2007-000710-37-DE
ZLB06_006CR
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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