Multifocal motor neuropathy MedDRA version: 12.0 Level: LLT Classification code 10065579 Term: Multifocal motor neuropathy
Conditions
Interventions
Trade Name: KIOVIG 100 mg/ml solution for infusion
Product Name: IGIV, 10%
Pharmaceutical Form: Solution for infusion
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentrati
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained from the subject prior to any study-related procedures and study product administration. 2. Diagnosis of definite or probable MMN based on the criteria of the American Association of Electrodiagnostic Medicine. Conduction block can be defined by a drop in amplitude. Diagnosis can be based on chart records a. Hand grip (finger flexor) weakness of Medical Research Council (MRC) grade 4 or less or equivalent, at disease onset or appearing prior to screening. b. No upper motor signs. c. No bulbar or cranial signs or symptoms. d. No clinically identifiable sensory abnormalities. 3. Must be on a stable regimen of IGIV for at least 3 months prior to enrollment. 4. Treatment interval with IGIV of 2 to 5 weeks (+/- 3 days). 5. Dose of IGIV to be 0.4 to 2.0 g per kg bodyweight (BW) and infusion cycle. 6. Subjects are adults, male of female, at least 18 years of age. 7. If female and capable of bearing children - have a negative urine pregnancy test result at enrollment and agree to employ adequate birth control measures for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any clinical or electrophysiological evidence of coexisting neuropathy which may interfere with outcome assessments, such as diabetic neuropathy, toxic neuropathy, or neuropathy due to systemic lupus erythematosis. 2. Treatment with other immunosuppressive agents besides IGIV, which have demonstrated efficacy in MMN such as cyclophosphamide during the 3 months prior to enrollment (or treatment with Rituximab during the 12 months prior to enrollment). Pre-study treatment with mycophenolate mofetil or azathioprine is permitted if the dose has been stable for 3 months prior to enrollment. 3. Cerebrospinal fluid protein > 100 mg/dL (if done as part of a previous evaluation). 4. Subjects positive at enrollment for Hepatitis B surface antigen, PCR for HCV, and/or PCR for HIV Type 1. 5. Subjects with levels of alanine aminotransferase (ALT) or aspartate aminotransferase (ASP) > 2.5 times the upper limit of normal. 6. Subjects with neutropenia (defined as an absolute neutrophil count [ANC] <= 1000/mm³) 7. Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal. 8. Subjects with malignancy other than adequately treated basal cell or squameous cell carcinoma of the skin or carcinoma in situ of the cervix. 9. Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident). 10. Subjects with an ongoing hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV. 11. Subjects with immunoglobulin A deficiency and known anti-IgA antibodies. 12. If female, is pregnant or lactating at time of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with multifocal motor neuropathy (MMN).;Secondary Objective: Evaluation of additional efficacy measures for MMN. Additional safety analysis and categorization of adverse events.;Primary end point(s): Primary efficacy endpoints: - Grip strength in the more affected hand. - Upper limb (Part 6) subsection of the Guy's Neurological Disability Score (GNDS). Primary safety endpoints include: - The rate of temporally associated adverse events (AEs) per infusion, defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product, divided by the total number of infusions. - The proportion of subjects for whom the infusion rate for any infusion was reduced and/or the infusion was interrupted or stopped for any reason. - The proportion of subjects reporting one ore more moderate or severe AEs that begin during infusion or within 72 hours of completion of an infusion. | — |
Countries
Denmark
Outcome results
None listed