NeuromaPhase 2NCT01374191
Botulinum Toxin Type A for Neuroma Pain
A Phase 2 study testing onabotulinum toxin type-A and 2nd phase - onabotulinum toxin type-A in people with Neuroma, run by Southern Illinois University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuroma
- What is being tested?
- onabotulinum toxin type-A and 2nd phase - onabotulinum toxin type-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial of Botulinum Toxin Type A for Neuroma Pain
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
Read the 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
- Being tested
- onabotulinum toxin type-A, placebo, 2nd phase - onabotulinum toxin type-A
- Keywords
- botox, neuroma pain, pain, chronic pain, botulinum toxin, botulinum toxin A, botox and pain, botox and neuroma, botox treatment, onabotulinum, onabotulinum toxin, onabotulinum toxin type A
- Medical subject headings
- Neuroma, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinum toxin type-ADrug
Also called Botulinum Toxin Type A, Botox
1 injection of Btx-A
placeboOther
1 injection of saline solution
2nd phase - onabotulinum toxin type-ADrug
Also called Botulinum Toxin Type A, Botox
2 - 3 injections of Btx-A, specific to patient pain recurrence
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: onabotulinum toxin type-A |
| placebo | Placebo comparator | saline Receives: Other: placebo |
| 2nd phase - onabotulinum toxin type-A | Active comparator | 2 - 3 injections of Btx-A, specific to patient pain recurrence Receives: Drug: 2nd phase - onabotulinum toxin type-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of pain-free days
subjective evaluation of pain relief, using Subjective pain scales [visual analogue scale (VAS) and faces pain assessment]
Measured: change from baseline to 28 days
Secondary outcomes (5)
quality of life
SF-12v2® Health Survey - Pain Enhanced
Measured: change from baseline to 28 days
upper extremity function
Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure
Measured: change from baseline to 28 days
lower extremity function
Lower Extremity Functional Scale (LEFS)
Measured: change from baseline to 28 days
patient satisfaction
SF-12v2® Health Survey - Pain Enhanced
Measured: change from baseline to 28 days
quality-adjusted life-years
EuroQol (EQ-5D)
Measured: change from baseline to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJan 2015
- Primary completionMay 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeuromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A. Neumeister, MD, Principal investigator, Southern Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374191
- Sponsor's protocol ID
- NEU-SIUSOM-11-002
- Status last verified
- Aug 2015
- First submitted
- 13 Jun 2011
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21134617Neumeister 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.
PubMed 19568080
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial of Botulinum Toxin Type A for Neuroma Pain
- ClinicalTrials.gov ID
- NCT01374191
- Acronym / sponsor ID
- NEU-SIUSOM-11-002
- Conditions
- Neuroma
- Keywords
- botox, neuroma pain, pain, chronic pain, botulinum toxin, botulinum toxin A, botox and pain, botox and neuroma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| onabotulinum toxin type-A | Active comparator | Drug: onabotulinum toxin type-A1 injection of Btx-A, or up to 4 injections of Btx-A during the 1-year study period if pain recurs |
| placebo | Placebo comparator | Other: placebosaline |
| 2nd phase - onabotulinum toxin type-A | Active comparator | Drug: 2nd phase - onabotulinum toxin type-A2 - 3 injections of Btx-A, specific to patient pain recurrence |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| onabotulinum toxin type-AAlso: Botulinum Toxin Type A, Botox1 injection of Btx-A | Drug | onabotulinum toxin type-A |
| placebo1 injection of saline solution | Other | placebo |
| 2nd phase - onabotulinum toxin type-AAlso: Botulinum Toxin Type A, Botox2 - 3 injections of Btx-A, specific to patient pain recurrence | Drug | 2nd phase - onabotulinum toxin type-A |
Primary outcome
number of pain-free days
Time frame: change from baseline to 28 days
subjective evaluation of pain relief, using Subjective pain scales [visual analogue scale (VAS) and faces pain assessment]
5 secondary outcomes
quality of life
Time frame: change from baseline to 28 days
upper extremity function
Time frame: change from baseline to 28 days
lower extremity function
Time frame: change from baseline to 28 days
patient satisfaction
Time frame: change from baseline to 28 days
quality-adjusted life-years
Time frame: change from baseline to 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 21134617Neumeister 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.
- Background: PubMed 19568080Neumeister 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.
- U.S. Food \& Drug Administration webpage on drugs with consumer information linksLink provided by the sponsor.
- U.S. Food and Drug Administration search page for FDA approved drug productsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A. Neumeister, MD principal investigator
Southern Illinois University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing onabotulinum toxin type-A and 2nd phase - onabotulinum toxin type-A in people with Neuroma, run by Southern Illinois University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of pain-free days (time frame: change from baseline to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01374191, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.