A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND
- Conditions
- Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN.MedDRA version: 9.1Level: LLTClassification code 10036105Term: Polyneuropathy
- Registration Number
- EUCTR2007-000710-37-IT
- Lead Sponsor
- CSL Behring AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
· 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
· 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method