10 Participants Needed

Botox for Neuropathic Pain

IM
Overseen ByIsabel Moreno Hay, DDS PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Isabel Moreno Hay
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT study concluded that BoNT-A could be used as a preventive therapy in chronic migraine patients and FDA approval was obtained. According to the International Association for the Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there are no clinical trials published investigating the effect of intraoral administration of BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to investigate the potential therapeutic effect of intraoral administration of BoNT-A in patients suffering from continuous neuropathic pain. HYPOTHESIS: There will be statistically significant differences in reported pain intensity after the intraoral administration of BOTOX® in patients suffering from chronic continuous dentoalveolar neuropathic pain. A single subject experiment will be conducted with 10 patients where 50 U of BonT-A will be injected into the painful dentoalveolar area. Eligible subjects will complete a pain diary indicating their pain intensity by means of a visual analog scale during one month to establish a baseline. After the first injection, subjects will continue to monitor the VAS daily for 3 months and the infiltration will be repeated a second time following the same protocol. Patient's response will be monitored with the daily pain diary.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have intractable pain to conventional treatments like anticonvulsants, SNRIs, or tricyclic antidepressants, which suggests you might continue them. Please confirm with the trial coordinators.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should have intractable pain despite using conventional treatments like anticonvulsants, SNRIs, or tricyclic antidepressants, which suggests you might continue your current medications.

What data supports the idea that Botox for Neuropathic Pain is an effective drug?

The available research shows that Botox can be effective in treating neuropathic pain. For example, one study found that Botox relieved pain in a case of post-herpetic neuralgia, with the pain relief lasting 52 days. Another study indicated that Botox improved pain perception in people with diabetic neuropathy. Additionally, a review of various studies concluded that Botox is effective for certain types of neuropathic pain, like postherpetic neuralgia and trigeminal neuralgia, and probably effective for others, such as posttraumatic neuralgia and painful diabetic neuropathy. This suggests that Botox can be a useful option for managing neuropathic pain, especially when other treatments don't work well.12345

What data supports the effectiveness of the drug Botox for treating neuropathic pain?

Research shows that Botox (onabotulinumtoxinA) can help relieve neuropathic pain, such as in cases of post-herpetic neuralgia and painful diabetic neuropathy. Studies indicate it is effective in reducing pain and improving sensory perception in these conditions.12345

What safety data exists for Botox in treating neuropathic pain?

Studies indicate that onabotulinumtoxinA (Botox) is generally safe and well-tolerated for treating neuropathic pain, with minimal adverse events. A case of neuropathic pruritus was reported, but it was resolved. A randomized trial assessed the safety and efficacy of repeated injections, and a review highlighted positive results, though more high-quality trials are needed. Adverse events are similar to other botulinum toxin products.14678

Is Botox safe for treating neuropathic pain?

Studies show that Botox (onabotulinumtoxinA) is generally safe with minimal side effects, though some patients may experience mild reactions like pruritus (itching).14679

Is the drug Botox a promising treatment for neuropathic pain?

Yes, Botox shows promise as a treatment for neuropathic pain. Studies and reviews suggest it can effectively relieve pain in conditions like post-herpetic neuralgia and spinal cord injury-related pain. Many investigations report positive results, indicating its potential as a helpful option for managing neuropathic pain.1471011

How does the drug Botox differ from other treatments for neuropathic pain?

Botox (onabotulinum toxin A) is unique for neuropathic pain because it is injected directly into the affected area, providing targeted pain relief by blocking nerve signals, which is different from oral medications that affect the whole body. It has shown promising results in cases where other treatments have failed, offering pain relief for several weeks after a single injection.1471011

Research Team

JP

Jeffrey P Okeson, DMD

Principal Investigator

Associate Professor

Eligibility Criteria

This trial is for individuals with ongoing dentoalveolar pain that hasn't improved with standard oral or topical medications. Participants must have signs of trigeminal nerve dysfunction and no other sources of pain, not be allergic to Botox components, have no systemic nerve/muscle disorders, bleeding issues, swallowing/breathing difficulties, and not be pregnant or breastfeeding.

Inclusion Criteria

My nerve pain does not improve with standard pain medication.
Subject consent to participate in the study.
I have ongoing dental pain with signs of nerve issues in my face, and other causes have been excluded.

Exclusion Criteria

I have breathing problems.
You are allergic to onabotulinum toxin or any of its ingredients.
I have a bleeding disorder.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Monitoring

Eligible subjects complete a pain diary indicating their pain intensity by means of a visual analog scale during one month to establish a baseline

4 weeks

Treatment

50 U of BoNT-A is injected into the painful dentoalveolar area, and subjects monitor VAS daily for 3 months. The infiltration is repeated a second time following the same protocol

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment using a daily pain diary

4 weeks

Treatment Details

Interventions

  • onabotulinum toxin A
Trial OverviewThe study tests the effect of injecting 50 units of onabotulinum toxin A (Botox) into areas affected by neuropathic pain in the mouth. It's a small-scale experiment involving 10 patients who will record their pain levels daily before and after two injections over three months.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: BOTOXExperimental Treatment1 Intervention
Onabotulinum toxin A is distributed in 50 unit (50U) vacuum-dried powder bottles by Allergan (BOTOX (R)) for reconstitution only with sterile, preservative-free 0.9% Sodium Chloride Injection prior to injection. 1 mL of diluent will be drawn up to obtain a resulting dose of 10 U per 0.2 mL and injected into the vial. The BOTOX(R) will then be gently mixed with the saline by rotating the vial. The date and time of reconstitution will be recorded on the package on the label. BOTOX should be administered within 24 hours after reconstitution and stored in a refrigerator (2-8 °C). Each patient will receive 50 U of onabotulinum toxin A.

onabotulinum toxin A is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Botox for:
  • Adult spasticity
  • Cervical dystonia in adults
  • Severe axillary hyperhidrosis
  • Blepharospasm associated with dystonia in a beneficiary 12 years of age and older
  • Strabismus in a beneficiary 12 years of age and older
🇪🇺
Approved in European Union as Botox for:
  • Muscle spasms
  • Detrusor muscle contraction
  • Excessive sweat gland activity
  • Chronic migraine prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Isabel Moreno Hay

Lead Sponsor

Trials
2
Recruited
50+

Allergan Sales, LLC

Industry Sponsor

Trials
10
Recruited
6,700+

AbbVie

Industry Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

An 80-year-old man with severe post-herpetic neuralgia experienced significant pain relief after receiving multiple injections of botulinum toxin type A (BTX-A), which is not commonly used for neuropathic pain.
The pain relief lasted for 52 days, suggesting that BTX-A may be an effective treatment option for patients with neuropathic pain that does not respond to standard therapies.
Botulinum toxin A relieved neuropathic pain in a case of post-herpetic neuralgia.Liu, HT., Tsai, SK., Kao, MC., et al.[2018]
Botulinum neurotoxins (BoNTs), particularly onabotulinumtoxinA, have been shown to be effective in treating neuropathic pain, with strong evidence supporting their use in conditions like postherpetic neuralgia and trigeminal neuralgia.
BoNTs are probably effective for other types of neuropathic pain, such as posttraumatic neuralgia and painful diabetic neuropathy, but more research is needed to determine the best dosages and injection techniques for optimal results.
Botulinum Toxin Treatment of Neuropathic Pain.Mittal, SO., Safarpour, D., Jabbari, B.[2018]
Botulinum toxin type A (BoNT-A) significantly reduces mechanical and cold allodynia in a rat model of neuropathic pain, with effective doses ranging from 10 to 40 U.kg(-1).
However, higher doses of 30 and 40 U.kg(-1) were associated with decreased motor performance, indicating a potential side effect that needs to be considered in treatment.
The effects of botulinum toxin A on mechanical and cold allodynia in a rat model of neuropathic pain.Park, HJ., Lee, Y., Lee, J., et al.[2013]

References

Botulinum toxin A relieved neuropathic pain in a case of post-herpetic neuralgia. [2018]
Botulinum Toxin Treatment of Neuropathic Pain. [2018]
The effects of botulinum toxin A on mechanical and cold allodynia in a rat model of neuropathic pain. [2013]
Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial. [2022]
OnabotulinumtoxinA improves tactile and mechanical pain perception in painful diabetic polyneuropathy. [2022]
Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. [2018]
Botulinum Neurotoxin for the Treatment of Neuropathic Pain. [2020]
A review of AbobotulinumtoxinA (Dysport). [2016]
OnabotulinumtoxinA effectiveness on chronic migraine, negative emotional states and sleep quality: a single-center prospective cohort study. [2022]
A clinical review of the use of Botulinum Toxin type A in managing central neuropathic pain in patients with spinal cord injury. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Subcutaneous and perineural botulinum toxin type a for neuropathic pain: a descriptive review. [2013]