Phase 2
N=8
A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)
Multifocal Motor Neuropathy (MMN)
Bottom Line
View on ClinicalTrials.gov: NCT00701662 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Change From Baseline to Week 24 in Muscle Strength — 0.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vivaglobin (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in Muscle Strength |
0.4 | — |
| PRIMARY Mean Overall MRC Score at Baseline and Week 24 |
178.3; 184.3 | — |
| SECONDARY Change From Baseline to Week 24 in Disability |
0.1 | — |
| SECONDARY Mean Disability Score at Baseline and Week 24 |
2.0; 1.9 | — |
| SECONDARY Change From Baseline to the Completion Visit in Motor Function |
0.4 | — |
| SECONDARY Mean Motor Function Score at Screening and Week 25 |
5.5; 4.6 | — |
| SECONDARY Health-Related Quality of Life at Baseline and Week 25 |
2.6; 1.3; 1.0; 1.1; 2.9 | — |
| SECONDARY Treatment Satisfaction at Baseline and Week 25 |
60.76; 91.67; 70.30; 89.29; 75.01; 96.28 | — |
| SECONDARY Overall Health Status at Baseline and Week 25 |
72.1; 73.9 | — |
| SECONDARY Number of Patients With Adverse Events (AEs) by Severity and Relatedness |
4; 3; 2; 0; 4; 0 | — |
| SECONDARY Rate of AEs by Severity and Relatedness |
0.104; 0.093; 0.011; 0.000; 0.038; 0.000 | — |
| SECONDARY Number of Patients With Local/Injection Site Reactions |
1; 1; 1; 1 | — |
| SECONDARY Number of Patients With Clinically Relevant Changes in Laboratory Parameters |
— | — |
| SECONDARY Number of Patients With Clinically Relevant Changes in Vital Signs |
— | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00701662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.