Overview

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Withdrawn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