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

NCT00701662 | Completed Phase 2 Results

• 3 other identifiers: 1464ZLB06_006CR2007-000710-37
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 3

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)

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Week 24 in Muscle Strength

  The change in Medical Research Council (MRC) score was determined at week 24 compared to baseline using descriptive statistics and nonparametric, two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available. The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline.

  Baseline to week 24

• Mean Overall MRC Score at Baseline and Week 24

  The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement.

  Baseline and week 24

Secondary Outcomes (12)

• Change From Baseline to Week 24 in Disability

  Baseline to week 24

• Mean Disability Score at Baseline and Week 24

  Baseline and Week 24

• Change From Baseline to the Completion Visit in Motor Function

  Baseline to the completion visit (up to week 25)

• Mean Motor Function Score at Screening and Week 25

  Screening and week 25

• Health-Related Quality of Life at Baseline and Week 25

  At baseline and week 25

Study Arms (1)

Vivaglobin

EXPERIMENTAL

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).

Biological: Vivaglobin

Interventions

Vivaglobin BIOLOGICAL

Also known as: Human Normal Immunoglobulin

Vivaglobin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (3)

San Raffaele Hospital

Milan, Italy

Location

Inselspital

Bern, Switzerland

Location

Dept. Clinical Immunology, Oxford Radcliffe Hospitals

Oxford, United Kingdom

Location

Related Publications (2)

• 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.

  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.

  PMID: 21692906 RESULT

MeSH Terms

Interventions

Vivaglobin; gamma-Globulins

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: CSL Behring

clinicaltrials@cslbehring.com

Use email contact

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 1, 2013
• Results First Posted: August 1, 2013

Record last verified: 2013-06

Locations

IT (1); GB (1); CH (1)