Botulinum Toxin Type A for Neuroma Pain

• Status: Withdrawn
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if botulinum toxin type A (Btx-A) is an effective treatment for painful neuromas. The ideal therapy for painful neuromas would be effective, non-addictive, safe, localized, and cost-effective treatment. At the same time, the therapy would also address the complex peripheral and central mechanisms. Btx-A is a potential treatment that addresses each of these requirements while preserving the existing sensation and function.

Study Hypothesis: Btx-A injection relieves neuroma pain better than a placebo

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern Illinois University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Male or female

• aged 18-75 years

• diagnosed with neuroma pain

• able to return/be available for follow-up evaluations

• willingness and ability to give informed consent

Exclusion Criteria:

• positive for HIV/AIDS or otherwise immunocompromised

• history of neuromuscular disease

• reported allergy to BOTOX®

• history or symptoms of any significant medical problem in the last year (i.e., bradycardia, impaired cardiovascular function, liver disease)

• symptoms of infection or illness with initial enrollment

• pregnant or lactating women

• unable or unwilling to maintain abstinence or use contraception for 28 days following all injections

• cognitively impaired patients unable to give informed consent