NCT01374191

Brief 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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
3.6 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

June 13, 2011

Last Update Submit

August 25, 2015

Conditions

Neuroma

Keywords

botoxneuroma painpainchronic painbotulinum toxinbotulinum toxin Abotox and painbotox and neuromabotox treatmentonabotulinumonabotulinum toxinonabotulinum toxin type A

Outcome Measures

Primary Outcomes (1)

  • number of pain-free days

    subjective evaluation of pain relief, using Subjective pain scales \[visual analogue scale (VAS) and faces pain assessment\]

    change from baseline to 28 days

Secondary Outcomes (5)

  • quality of life

    change from baseline to 28 days

  • upper extremity function

    change from baseline to 28 days

  • lower extremity function

    change from baseline to 28 days

  • patient satisfaction

    change from baseline to 28 days

  • quality-adjusted life-years

    change from baseline to 28 days

Study Arms (3)

onabotulinum toxin type-A

ACTIVE COMPARATOR

1 injection of Btx-A, or up to 4 injections of Btx-A during the 1-year study period if pain recurs

Drug: onabotulinum toxin type-A

placebo

PLACEBO COMPARATOR

saline

Other: placebo

2nd phase - onabotulinum toxin type-A

ACTIVE COMPARATOR

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

Drug: 2nd phase - onabotulinum toxin type-A

Interventions

onabotulinum toxin type-ADRUG

1 injection of Btx-A

Also known as: Botulinum Toxin Type A, Botox
onabotulinum toxin type-A
placeboOTHER

1 injection of saline solution

placebo
2nd phase - onabotulinum toxin type-ADRUG

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

Also known as: Botulinum Toxin Type A, Botox
2nd phase - onabotulinum toxin type-A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Publications (2)

  • Neumeister MW. Botulinum toxin type A in the treatment of Raynaud's phenomenon. J Hand Surg Am. 2010 Dec;35(12):2085-92. doi: 10.1016/j.jhsa.2010.09.019.

    PMID: 21134617BACKGROUND

  • Neumeister MW, Chambers CB, Herron MS, Webb K, Wietfeldt J, Gillespie JN, Bueno RA Jr, Cooney CM. Botox therapy for ischemic digits. Plast Reconstr Surg. 2009 Jul;124(1):191-201. doi: 10.1097/PRS.0b013e3181a80576.

    PMID: 19568080BACKGROUND

Related Links

MeSH Terms

Conditions

NeuromaPainChronic Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Nerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Michael A. Neumeister, MD

    Southern Illinois University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 15, 2011

Study Start

January 1, 2015

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

US(1)