Botox for Neuropathic Pain

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Isabel Moreno Hay

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

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.

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. ^{1 2 3 4 5}

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. ^{1 4 6 7 8}

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. ^{1 4 7 9 10}

Research Team

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.

Treatment Details

Interventions

• onabotulinum toxin A (Neurotoxin)

Trial Overview The 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

Group I: BOTOX Experimental Treatment 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Orofacial Pain Center Lexington, KY

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

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum Toxin Treatment of Neuropathic Pain. Mittal, SO., Safarpour, D., Jabbari, B.[2018]

In a randomized, double-blind, placebo-controlled trial involving 152 patients with peripheral neuropathic pain, botulinum toxin A significantly reduced pain intensity over 24 weeks compared to placebo, demonstrating its efficacy as a treatment option.

The only reported adverse effect was pain at the injection site, which occurred similarly in both the botulinum toxin A and placebo groups, indicating that the treatment is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial. Attal, N., de Andrade, DC., Adam, F., et al.[2022]

AbobotulinumtoxinA, approved by the FDA in 2009 for facial aesthetics, is generally well tolerated and has a safety profile similar to other botulinum neurotoxin type A products.

The article discusses various clinical applications and indications for abobotulinumtoxinA, along with important information on handling, storage, and dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of AbobotulinumtoxinA (Dysport). Lorenc, ZP., Kenkel, JM., Fagien, S., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin A relieved neuropathic pain in a case of post-herpetic neuralgia. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Botulinum Toxin Treatment of Neuropathic Pain. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The effects of botulinum toxin A on mechanical and cold allodynia in a rat model of neuropathic pain. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA improves tactile and mechanical pain perception in painful diabetic polyneuropathy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pruritus associated with onabotulinumtoxinA treatment of neuromuscular pain. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Botulinum Neurotoxin for the Treatment of Neuropathic Pain. [2020]

8. England pubmed.ncbi.nlm.nih.gov

A review of AbobotulinumtoxinA (Dysport). [2016]

9. England pubmed.ncbi.nlm.nih.gov

A clinical review of the use of Botulinum Toxin type A in managing central neuropathic pain in patients with spinal cord injury. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous and perineural botulinum toxin type a for neuropathic pain: a descriptive review. [2013]