GAMMAGARD LIQUID Clinical Trial: Multifocal Motor Neuropathy (MMN)
- Study design
- Improved grip strength
- Reduced disability
- Efficacy in dexterity
- Accelerated switch
Study design1
Largest controlled clinical trial for MMN to date1
A phase III, randomized withdrawal, double-blind, placebo-controlled, cross-over, 60-week study to assess the efficacy, safety, and tolerability of GAMMAGARD LIQUID in 44 adult patients with MMN.1
Open-label GAMMAGARD LIQUID
Patients were randomized 1:1 to either double-blind treatment of intravenous immune globulin (IVIG) (GAMMAGARD LIQUID) followed by placebo for 12 weeks each or the reverse. Open-label IVIG was administered for 12 weeks at the beginning and end of the study for clinical stabilization, and between double-blinded periods to prevent a carry-over effect.1,2
Efficacy endpoints1,2
The co-primary efficacy endpoints were maximal grip strength in the more affected hand measured with a DynEx digital dynamometer, and disability as determined by the upper limb portion of GNDS.1,2
Secondary efficacy outcomes included requirement for accelerated switch, and time required for the 9-hole peg board test with the dominant and non-dominant hand.1
GNDS=Guy’s Neurological Disability Scale
Improved grip strength2
GAMMAGARD LIQUID significantly improved grip strength in the more affected hand compared with placebo.2
The difference in relative change in mean grip strength for GAMMAGARD LIQUID and placebo of 22.30% (95% CI 9.92–34.67) was statistically significant (p<0.001).2*
SEQUENCE 1: GAMMAGARD LIQUID to placebo
Placebo -30.52% (SD 29.68); GAMMAGARD LIQUID -16.36% (SD 32.84).2
Relative mean change calculated by subtracting the GAMMAGARD LIQUID value from the placebo value.
SEQUENCE 2: Placebo to GAMMAGARD LIQUID
GAMMAGARD LIQUID +1.46% (SD 10.72); placebo -29.19% (SD 39.95).2
Relative mean change calculated by subtracting the placebo value from the GAMMAGARD LIQUID value.
*Measured in the more affected hand following treatment (ITT; N=41)
CI=confidence interval
GNDS=Guy's Neurological Disability Scale
ITT=intent to treat
SD=standard deviation
CI=confidence interval
GNDS=Guy's Neurological Disability Scale
ITT=intent to treat
SD=standard deviation
Reduced disability1,2
Three times more patients receiving placebo had worsening disability than those receiving GAMMAGARD LIQUID (p=0.021).1,2
Proportion of patients who deteriorated according to the upper limbs section of the GNDS (%)
Adapted from Hahn et al. 20131
ITT; N=42
Demonstrated efficacy in dexterity1,2
GAMMAGARD LIQUID maintained dexterity, measured by time to complete 9-hole peg board test, compared with a decrease in dexterity with placebo (p<0.001).1,2
Adapted from Hahn et al. 20131
9-hole peg board test results
With the dominant hand, subjects required:
- 17% longer to complete the 9-hole peg test (a measure of dexterity) at the end of the placebo period compared with baseline1,2
- 1.2% longer to complete the 9-hole peg test at the end of the GAMMAGARD LIQUID treatment period compared with baseline1,2
With the non-dominant hand, subjects required:
- 33% longer to complete the 9-hole peg test at the end of the placebo period compared with baseline1,2
- 6.7% longer to complete the 9-hole peg test at the end of the GAMMAGARD LIQUID treatment period compared with baseline1,2
Functional deterioration: accelerated switch1,2
Over two-thirds of patients required an accelerated switch from blinded treatment to open-label GAMMAGARD LIQUID vs one patient treated with GAMMAGARD LIQUID (p<0.001).1,2
Review safety information
Review important information, including contraindications and other specific warnings and precautions, to consider when prescribing and monitoring patients treated with GAMMAGARD LIQUID.
Review the safety profile established in the largest controlled clinical trial for MMN to date1,2
See safety profile