Status:
COMPLETED
A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)
Lead Sponsor:
CSL Behring
Conditions:
Multifocal Motor Neuropathy (MMN)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00701662
Start Date
November 1 2007
End Date
January 1 2009
Last Update
August 1 2013
Active Locations (3)
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1
San Raffaele Hospital
Milan, Italy
2
Inselspital
Bern, Switzerland
3
Dept. Clinical Immunology, Oxford Radcliffe Hospitals
Oxford, United Kingdom