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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00701662
First received: June 18, 2008
Last updated: May 1, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Multifocal Motor Neuropathy (MMN)
 Biological: Human Normal Immunoglobulin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Study of Subcutaneous Immunoglobulin in Patients With Multifocal Motor Neuropathy (MMN)

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Muscle strength of the patients measured using a modified Medical Research Council (MRC) scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disability, scored using modified Guy's Neurological Disability Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Individual Functional Test of four common daily tasks (motor function) [ Time Frame: bi-weekly and 24 weeks ] [ Designated as safety issue: No ]
  • Quality of Life (QoL), using an adapted QoL questionnaire [ Time Frame: Comparing QoL measured at screening with QoL completion visit in week 25 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: November 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vivaglobin Biological: Human Normal Immunoglobulin
0.1 to 0.5 g/kg body weight per week
Other Name: Vivaglobin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • ASAT or 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701662

Locations
Germany
Neurologische Klinik, Heinrich-Heine-University
Düsseldorf, Germany
Italy
San Raffaele Hospital
Milan, Italy
Switzerland
Inselspital
Bern, Switzerland
United Kingdom
Dept. Clinical Immunology, Oxford Radcliffe Hospitals
Oxford, United Kingdom
Sponsors and Collaborators
CSL Behring
Investigators
Principal Investigator: Matthias Sturzenegger, MD Inselspital, University Hospital of Bern
Principal Investigator: Bernd Kieseier, MD Neurologische Klinik, Heinrich-Heine-University, Düsseldorf
Principal Investigator: Giancarlo Comi, MD San Raffaele Hospital
Principal Investigator: Siraj Misbah, MD Dept. Clinical Immunology, Oxford Radcliffe Hospitals
  More Information

Additional Information:
Click here to request more information about this study  This link exits the ClinicalTrials.gov site

Publications:
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.

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00701662     History of Changes
Other Study ID Numbers: 1464, ZLB06_006CR, 2007-000710-37
Study First Received: June 18, 2008
Last Updated: May 1, 2012
Health Authority: Switzerland: Swissmedic
Germany: Paul-Ehrlich-Institut
Italy: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Immunoglobulins
 Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013