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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00701662
Date of registration: 18/06/2008
Prospective Registration: No
Primary sponsor: CSL Behring
Public title: A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)
Scientific title: A Multicentre Study of Subcutaneous Immunoglobulin (SCIG) in Patients With Multifocal Motor Neuropathy (MMN)
Date of first enrolment: November 2007
Target sample size: 8
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00701662
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Germany Italy Switzerland United Kingdom
Contacts
Name:     Siraj Misbah, MD
Address: 
Telephone:
Email:
Affiliation:  Dept. Clinical Immunology, Oxford Radcliffe Hospitals
Name:     Matthias Sturzenegger, MD
Address: 
Telephone:
Email:
Affiliation:  Inselspital, University Hospital of Bern
Name:     Bernd Kieseier, MD
Address: 
Telephone:
Email:
Affiliation:  Neurologische Klinik, Heinrich-Heine-University, Düsseldorf
Name:     Giancarlo Comi, MD
Address: 
Telephone:
Email:
Affiliation:  San Raffaele Hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Multifocal Motor Neuropathy (MMN)
Intervention(s)
Biological: Vivaglobin
Primary Outcome(s)
Change From Baseline to Week 24 in Muscle Strength [Time Frame: Baseline to week 24]
Mean Overall MRC Score at Baseline and Week 24 [Time Frame: Baseline and week 24]
Secondary Outcome(s)
Change From Baseline to the Completion Visit in Motor Function [Time Frame: Baseline to the completion visit (up to week 25)]
Change From Baseline to Week 24 in Disability [Time Frame: Baseline to week 24]
Health-Related Quality of Life at Baseline and Week 25 [Time Frame: At baseline and week 25]
Mean Disability Score at Baseline and Week 24 [Time Frame: Baseline and Week 24]
Mean Motor Function Score at Screening and Week 25 [Time Frame: Screening and week 25]
Number of Patients With Adverse Events (AEs) by Severity and Relatedness [Time Frame: For the duration of the study, up to Week 25]
Number of Patients With Clinically Relevant Changes in Laboratory Parameters [Time Frame: Baseline to Week 25]
Number of Patients With Clinically Relevant Changes in Vital Signs [Time Frame: Baseline to Week 25]
Number of Patients With Local/Injection Site Reactions [Time Frame: For the duration of the study, up to Week 25]
Overall Health Status at Baseline and Week 25 [Time Frame: Baseline and week 25]
Rate of AEs by Severity and Relatedness [Time Frame: For the duration of the study, up to Week 25]
Treatment Satisfaction at Baseline and Week 25 [Time Frame: At baseline and week 25]
Secondary ID(s)
1464
2007-000710-37
ZLB06_006CR
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 01/08/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00701662
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