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

Condition(s) targeted: Multifocal Motor Neuropathy (MMN)

Intervention: Vivaglobin (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Matthias Sturzenegger, MD, Principal Investigator, Affiliation: Inselspital, University Hospital of Bern
Bernd Kieseier, MD, Principal Investigator, Affiliation: Neurologische Klinik, Heinrich-Heine-University, Düsseldorf
Giancarlo Comi, MD, Principal Investigator, Affiliation: San Raffaele Hospital
Siraj Misbah, MD, Principal Investigator, Affiliation: Dept. Clinical Immunology, Oxford Radcliffe Hospitals

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.

Official title: A Multicentre Study of Subcutaneous Immunoglobulin (SCIG) in Patients With Multifocal Motor Neuropathy (MMN)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change From Baseline to Week 24 in Muscle Strength

Mean Overall MRC Score at Baseline and Week 24

Secondary outcome:

Change From Baseline to Week 24 in Disability

Mean Disability Score at Baseline and Week 24

Change From Baseline to the Completion Visit in Motor Function

Mean Motor Function Score at Screening and Week 25

Health-Related Quality of Life at Baseline and Week 25

Treatment Satisfaction at Baseline and Week 25

Overall Health Status at Baseline and Week 25

Number of Patients With Adverse Events (AEs) by Severity and Relatedness

Rate of AEs by Severity and Relatedness

Number of Patients With Local/Injection Site Reactions

Number of Patients With Clinically Relevant Changes in Laboratory Parameters

Number of Patients With Clinically Relevant Changes in Vital Signs

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

San Raffaele Hospital, Milan, Italy

Inselspital, Bern, Switzerland

Dept. Clinical Immunology, Oxford Radcliffe Hospitals, Oxford, United Kingdom

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Starting date: November 2007
Last updated: June 2, 2013