Phase 2
Completed N=8
A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)
Multifocal Motor Neuropathy (MMN)
Source: ClinicalTrials.gov NCT00701662 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline to Week 24 in Muscle Strength — 0.4 score on a scale
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.
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 |
— | — |
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. Informational only — not medical advice.