Trials / Completed
CompletedNCT00666263
Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immune Globulin Intravenous (human), 10% | Dose: Previous dose with 3, 4, or 6 cycles depending on previous schedule (patient specific) |
| BIOLOGICAL | 0.25% human albumin solution (Placebo) | 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 |
Timeline
- Start date
- 2008-08-22
- Primary completion
- 2011-08-11
- Completion
- 2011-08-11
- First posted
- 2008-04-24
- Last updated
- 2021-05-19
- Results posted
- 2013-03-13
Locations
17 sites across 3 countries: United States, Canada, Denmark
Source: ClinicalTrials.gov record NCT00666263. Inclusion in this directory is not an endorsement.