drugset / Trial / NCT00666263
Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy
RandomizedCrossoverTriple-blindTreatment
Summary
The purpose of the study is to evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of IGIV, 10% in subjects with Multifocal Motor Neuropathy.
Timeline
- Start
- 2008-08-22
- Primary completion
- 2011-08-11
- Completion
- 2011-08-11
Publications
- Background Merkies IS, Schmitz PI, van der Meche FG, Samijn JP, van Doorn PA; Inflammatory Neuropathy Cause and Treatment (INCAT) group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2002 May;72(5):596-601. doi: 10.1136/jnnp.72.5.596.
- Background Sharrack B, Hughes RA. The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler. 1999 Aug;5(4):223-33. doi: 10.1177/135245859900500406.
- Results Koski CL, Schiff RI, Oh M, Lee D. Characteristics of patients with multifocal motor neuropathy enrolled in a randomized controlled trial of intravenous gammaglobulin. Poster. 63rd Annual Meeting of American Academy of Neurology (AAN), April 9-16, 2011, Honolulu, HI, USA.
- Li Z, Roepcke S, Franke R, Yel L. Dose-exposure-efficacy response of intravenous immunoglobulin G 10% in multifocal motor neuropathy. Ann Clin Transl Neurol. 2024 Aug;11(8):1977-1987. doi: 10.1002/acn3.52098. Epub 2024 Jul 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.4 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |