Botulinum Toxin Type A for Neuroma Pain

IRB Number

12-512

ClinicalTrials.gov Identifier

NCT01374191

Trial Status

Open for Enrollment
Phase 2

Why is this study being done?

The purpose of this study is to examine the short- and long-term efficacy of botulinum toxin type-A (BOTOX®, Allergan, Inc.) in treating pain caused by damage to a nerve. Participants will receive either Btx-A or placebo (sterile saline injection).

Who is eligible to participate?

Males and females, 18-90 years of age with neuroma pain.

What is involved?

All participants will have a medical history and physical exam, complete questionnaires about pain and quality of life, receive a digit transcutaneous oxygen saturation test (non-invasive measurement of the oxygen level in the blood), have imaging to confirm the diagnosis if necessary, and attend follow-up appointments. Participants will be randomized and given either BOTOX® or a placebo (saline) at the first appointment.

How long is the study?

The study is a long-term follow-up study in which the participants will be contacted several times over 5 years to see how long the effects of BOTOX® injection(s) last.

Who can I contact for additional information?

Please contact Jennifer Koechle, MPH, at (217) 545-7014 or email jkoechle@siumed.edu .

Who is the Principal Investigator of this study?

Michael W. Neumeister, MD

Where is the trial located?

Springfield, Illinois