Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy

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

Outcome

Met primary endpoint

registry p = 0.005; Difference in least squared means 35.13 (95% CI 8.81 to 61.46); ANOVA NCT00666263 ↗

registry Deterioration After Placebo, But Not IGIV, 10%: 35.7 (2.0 to 3.0) Proportion of participants NCT00666263 ↗

registry p = 0.021; McNemar NCT00666263 ↗

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

Indications