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Botulinum Toxin Type A for Neuroma Pain

NCT01374191 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-08-26

No results posted yet for this study

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

Conditions

  • Neuroma

Interventions

DRUG

onabotulinum toxin type-A

1 injection of Btx-A

OTHER

placebo

1 injection of saline solution

DRUG

2nd phase - onabotulinum toxin type-A

2 - 3 injections of Btx-A, specific to patient pain recurrence

Sponsors & Collaborators

  • Southern Illinois University

    lead OTHER

Principal Investigators

  • Michael A. Neumeister, MD · Southern Illinois University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-05-31
Completion
2017-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374191 on ClinicalTrials.gov