Botulinum Toxin Type A for Neuroma Pain

NCT ID: NCT01374191

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-09-30

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

Detailed Description

PROJECT SUMMARY OVERVIEW: 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, but 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. The investigators believe that Btx-A will be effective in eliminating both the exaggerated local pain response and centralization while maintaining an exceptional safety profile and potential for long-term effects without addictive properties.

STUDY AIMS: The aims of this proposal are to 1) examine the short-term efficacy of Btx-A injection compared to placebo in treating pain due to nerve damage, and 2) describe the long-term efficacy of Btx-A injection in treating pain due to nerve damage by measuring patient satisfaction and quality of life changes over time.

APPROACH: Forty patients will be enrolled; twenty to receive active treatment (Btx-A) and twenty to receive placebo (saline). Comparisons between treatment and placebo will occur during the first 28 days to determine Btx-A's short-term efficacy. Telephone follow-up visits will occur on Day 2 and Week 1. On Day 28, a telephone follow-up visit will occur, except in patients who are experiencing complications. Patients with complications or recurrent pain will return for a clinic visit. Post-assessment on Day 28 marks the beginning of the longitudinal observational study of patient outcomes. Placebo will no longer be used and patients still suffering from pain will be eligible for additional Btx-A injections. Patients may receive up to 4 injections of Btx-A during the 1-year study period if pain recurs. During the study period participants will be followed to collect data on pain-free intervals, subsequent treatment choices, patient satisfaction, and changes in quality of life and function. Group comparisons will be made to analyze results. Further stratifications for data analysis will be made as enrollment numbers allow to control for additional demographic and disease variables. Quality-adjusted life-years will be calculated to help determine the societal and individual cost of this treatment.

HYPOTHESIS: The investigators hypothesize that 1) Btx-A injection relieves neuroma pain better than a placebo within 28 days of injection, and 2) Btx-A injection relieves neuroma pain for longer than 28 days, improving patient quality of life. Through this study the investigators intend to further elucidate the efficacy of injected Btx-A on relieving chronic pain from nerve damage while characterizing the patients for whom this treatment is most effective.

Conditions

Neuroma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

onabotulinum toxin type-A

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

Group Type: ACTIVE_COMPARATOR

onabotulinum toxin type-A

Intervention Type: DRUG

1 injection of Btx-A

placebo

saline

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

1 injection of saline solution

2nd phase - onabotulinum toxin type-A

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

Group Type: ACTIVE_COMPARATOR

2nd phase - onabotulinum toxin type-A

Intervention Type: DRUG

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

Interventions

onabotulinum toxin type-A

1 injection of Btx-A

Intervention Type: DRUG

placebo

1 injection of saline solution

Intervention Type: OTHER

2nd phase - onabotulinum toxin type-A

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

Intervention Type: DRUG

Other Intervention Names

Botulinum Toxin Type A; Botox; Botulinum Toxin Type A; Botox

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Illinois University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A. Neumeister, MD

Role: PRINCIPAL_INVESTIGATOR

Southern Illinois University School of Medicine

Locations

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21134617 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19568080 (View on PubMed)

Related Links

http://www.fda.gov/Drugs/default.htm

U.S. Food \& Drug Administration webpage on drugs with consumer information links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

U.S. Food and Drug Administration search page for FDA approved drug products

Other Identifiers

NEU-SIUSOM-11-002

Identifier Type: -

Identifier Source: org_study_id