Objective: previous studies suggest that botulinum toxin A (BoNT/A) can reduce muscle
hyperactivity.
Research Design and Methods: a single-center, double-blind and placebo-controlled study
investigating the efficacy and safety of BoNT/A intramuscular injection for treating calf or
foot cramps refractory to common pharmacological drugs in patients with diabetic peripheral
neuropathy. Fifty patients were subdivided in two matched groups (cases and controls) and
BoNT/A (100 or 30 units) was injected for each side into the gastrocnemious or the small
flexor foot muscles, respectively, according to the predominance of leg or foot cramps.
Responders were evaluated again with a second BoNT/A administration.
The changes of pain intensity (primary outcome) and the changes in cramp frequency, the and
the Cramp Severity Scale (CSS) were evaluated over the course of 20 weeks after BoNT/A
administration.
Phase:
Phase 2
Details
Lead Sponsor:
Presidio Ospedaliero Garibaldi-Centro
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA