A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN)

• Conditions: 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: 9.1Level: LLTClassification code 10065579Term: Multifocal motor neuropathy

• Registration Number: EUCTR2007-000710-37-DE
• Lead Sponsor: CSL Behring AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified