Botulinum Toxin Type A for Neuroma Pain

Neuroma Clinical Trial

Official title:

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial of Botulinum Toxin Type A for Neuroma Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01374191
• Other study ID #: NEU-SIUSOM-11-002
• Status: Withdrawn
• Phase: Phase 2
• First received: June 13, 2011
• Last updated: August 25, 2015
• Start date: January 2015
• Est. completion date: September 2017

Study information

• Verified date: August 2015
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroma

Intervention

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

Locations

Country	Name	City	State
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Southern Illinois University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	quality of life	SF-12v2® Health Survey - Pain Enhanced	change from baseline to 28 days	No
Secondary	upper extremity function	Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure	change from baseline to 28 days	No
Secondary	lower extremity function	Lower Extremity Functional Scale (LEFS)	change from baseline to 28 days	No
Secondary	patient satisfaction	SF-12v2® Health Survey - Pain Enhanced	change from baseline to 28 days	No
Secondary	quality-adjusted life-years	EuroQol (EQ-5D)	change from baseline to 28 days	No

External Links

•   pharmaceutical company webpage with Botox information
•   U.S. Food & Drug Administration webpage on drugs with consumer information links
•   U.S. Food and Drug Administration search page for FDA approved drug products