CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 enrolled
Drug / intervention
Immune Globulin Intravenous (human), 10% +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00666263
NCT00666263Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor Neuropathy

Baxalta now part of Shire·interventional·Posted Apr 24, 2008·Updated May 19, 2021

In Brief

A Phase 3 clinical trial evaluating Immune Globulin Intravenous (human), 10% and 0.25% human albumin solution (Placebo) for Multifocal Motor Neuropathy. Completed, enrolled 50 participants across 17 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultifocal Motor Neuropathy
CountriesCanada, Denmark, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2008
Enrollment StartAug 22, 2008
Primary CompletionAug 11, 2011
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 18.2 years ago

Interventions

Immune Globulin Intravenous (human), 10%biological

Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific)

0.25% human albumin solution (Placebo)biological

Cross-over Period 1 (Randomized) / Cross-over Period 2 (opposite of the treatment received in Cross-over Period 1); Dose: Same volume/frequency as Stabilization Phase 1