Botulinum Toxin for Cramps in Diabetic Neuropathy

• Status: Completed
• Trial end date: 2017-05-03
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Presidio Ospedaliero Garibaldi-Centro
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• accepting to participate to the study;

• age ≥ 45 and ≤ 75 years ;

• diabetes duration > 5 years and diabetic distal symmetric neuropathy present;

• stable glycemic control with last HbA1c value <9.0% (or 75 mmol/mol);

• cramps present at rest in either calf or foot muscles or both for at least 6 months;

• occurrence of cramps at least 3 times a week in the previous three months;

• previous unsuccessful or poorly tolerated pharmacological treatment with at least two of the following drugs: carbamazepine, quinine, phenytoin, magnesium supplements, and benzodiazepines.

Exclusion Criteria:

• the presence of other neurological diseases and of nephropathy, macro-angiopathy, cirrhosis, and lumbar disc diseases or the inability to give informed consent because of cognitive impairment.

• Patients previously treated with BoNT/A for any reason were also excluded