A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)

NCT ID: NCT00701662

Last Updated: 2013-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-01-31

Brief Summary

The objective of this study is to assess efficacy, safety, and convenience of purified human antibodies administered under the skin in the treatment of MMN patients.

Conditions

Multifocal Motor Neuropathy (MMN)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vivaglobin

Vivaglobin® is a 16% (160 mg/mL) liquid formulation of human normal immunoglobulin for subcutaneous infusion. Subjects will receive weekly infusions of Vivaglobin® at a weekly dosage calculated based on previous intravenous immunoglobulin treatment (between 0.1 to 0.5 g/kg body weight per week).

Group Type: EXPERIMENTAL

Vivaglobin

Intervention Type: BIOLOGICAL

Interventions

Vivaglobin

Intervention Type: BIOLOGICAL

Other Intervention Names

Human Normal Immunoglobulin

Eligibility Criteria

Inclusion Criteria

• Patients with documented clinical diagnosis and electrophysiological evidence of MMN
• Patients who have previously responded to intravenous immunoglobulin (IVIG) and have been on stable treatment with IVIG for at least 12 weeks prior to screening
• Patients treated with the equivalent of ≥0.4g/kg body weight (bw) IVIG per month
• Provision of informed consent by patient

Exclusion Criteria

• Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) concentration >2.5 times the upper normal limit (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, might 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 >2.0g/kg bw IVIG per month

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Sturzenegger, MD

Role: PRINCIPAL_INVESTIGATOR

Inselspital, University Hospital of Bern

Bernd Kieseier, MD

Role: PRINCIPAL_INVESTIGATOR

Neurologische Klinik, Heinrich-Heine-University, Düsseldorf

Giancarlo Comi, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Hospital

Siraj Misbah, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. Clinical Immunology, Oxford Radcliffe Hospitals

Locations

San Raffaele Hospital

Milan, , Italy

Inselspital

Bern, , Switzerland

Dept. Clinical Immunology, Oxford Radcliffe Hospitals

Oxford, , United Kingdom

Countries

Italy; Switzerland; United Kingdom

References

Misbah S, et al. Efficacy and safety of subcutaneous immunoglobulin, Vivaglobin, in patients with multifocal motor neuropathy. Journal of Neurology 257(Suppl 1):S105-S106, 2010.

Reference Type: RESULT

Misbah SA, Baumann A, Fazio R, Dacci P, Schmidt DS, Burton J, Sturzenegger M. A smooth transition protocol for patients with multifocal motor neuropathy going from intravenous to subcutaneous immunoglobulin therapy: an open-label proof-of-concept study. J Peripher Nerv Syst. 2011 Jun;16(2):92-7. doi: 10.1111/j.1529-8027.2011.00330.x.

Reference Type: RESULT

PMID: 21692906 (View on PubMed)

Other Identifiers

ZLB06_006CR

Identifier Type: OTHER

Identifier Source: secondary_id

2007-000710-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1464

Identifier Type: -

Identifier Source: org_study_id