Botulinum Toxin for Cramps in Diabetic Neuropathy

NCT03238898 | Completed Phase 2

• 1 other identifier: btx for cramps
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Muscle Cramps Aggravated; Diabetes Mellitus

Keywords

muscle cramps; diabetic neuropathy; botulinum toxin

Outcome Measures

Primary Outcomes (1)

• pain intensity on a 0-10 severity scale

  the intensity of pain was rated on a scale 0 to 10, with 0 indicating no pain and 10 indicating "the worst pain imaginable"

  20 weeks

Secondary Outcomes (3)

• cramp frequency

  20 weeks

• the Cramp Severity Scale (CSS)

  20 weeks

• the Cramp Threshold Frequency (CTF)

  20 weeks

Study Arms (2)

botulinum toxin type A

ACTIVE COMPARATOR

Botulinum toxin type 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.

Drug: Botulinum toxin type A

Normal saline

PLACEBO COMPARATOR

The same dosage as the active group, but with normal saline alone were injected into the gastrocnemious or the small flexor foot muscles, respectively, according to the predominance of leg or foot cramps.

Other: Normal saline

Interventions

Botulinum toxin type A DRUG

botulinum toxin type A injections Botulinum toxin type 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.

botulinum toxin type A

Normal saline OTHER

Normal saline injections The same dosage as the active group, but with normal saline alone were injected into the gastrocnemious or the small flexor foot muscles, respectively, according to the predominance of leg or foot cramps.

Also known as: Placebo

Normal saline

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Presidio Ospedaliero Garibaldi-Centro: lead

Related Publications (1)

• Bertolasi L, Priori A, Tomelleri G, Bongiovanni LG, Fincati E, Simonati A, De Grandis D, Rizzuto N. Botulinum toxin treatment of muscle cramps: a clinical and neurophysiological study. Ann Neurol. 1997 Feb;41(2):181-6. doi: 10.1002/ana.410410209.

  PMID: 9029067 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Muscle Cramp; Diabetic Neuropathies

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: randomized, double-blind and placebo-controlled study

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: August 3, 2017
• Study Start: September 27, 2014
• Primary Completion: May 3, 2017
• Study Completion: May 3, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share