Status:
COMPLETED
Botulinum Toxin for Cramps in Diabetic Neuropathy
Lead Sponsor:
Presidio Ospedaliero Garibaldi-Centro
Conditions:
Muscle Cramps Aggravated
Diabetes Mellitus
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief 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 investigat...
Detailed Description
This was a single-center, randomized, double-blind, placebo-controlled prospective study. A consecutive series of 303 out-patients with type 2 diabetes was screened for muscle cramps.Patients were as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03238898
Start Date
September 27 2014
End Date
May 3 2017
Last Update
August 3 2017
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