Botox for Trigeminal Neuralgia

Recruiting in Palo Alto (17 mi)

Overseen by Meredith Barad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Stanford University

Must not be taking: Aminoglycosides

Disqualifiers: Secondary TN, Pregnant, Neuromuscular, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that your medication dose has been stable for the last 2 weeks. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Botox for treating trigeminal neuralgia?

Research shows that Botox (onabotulinumtoxinA) can significantly reduce pain in patients with trigeminal neuralgia, as seen in studies where patients reported less pain after treatment compared to those who received a placebo. In one study, patients experienced a notable decrease in pain scores three months after receiving Botox injections. ^{1 2 3 4 5}

Is Botox safe for treating trigeminal neuralgia?

Botox (OnabotulinumtoxinA) has been studied for treating trigeminal neuralgia and is generally considered safe and well-tolerated. In studies, no major adverse events were reported, indicating it is a safe option for this condition. ^{2 6 7 8 9}

How does the drug Botox differ from other treatments for trigeminal neuralgia?

Botox (OnabotulinumtoxinA) is unique for trigeminal neuralgia because it is injected directly into the affected nerves or muscles, providing targeted pain relief by blocking nerve signals, unlike oral medications that affect the whole body. It has shown promising results in reducing pain with minimal side effects, making it a novel option for those who do not respond well to standard treatments. ^{1 2 10 11 12}

Research Team

Meredith Barad, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals with Trigeminal Neuralgia, a condition causing facial pain. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I have tried at least 2 medications without success.

I am 18 years old or older.

I am legally recognized as able to make my own decisions.

Exclusion Criteria

I have been diagnosed with a specific type of facial pain.

I am not pregnant or breastfeeding.

I have a neuromuscular disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intradermal injections of OnabotulinumtoxinA or saline for trigeminal neuralgia

4 weeks

1 visit (in-person) for injection

Follow-up

Participants are monitored for changes in pain and attack frequency after treatment

3 months

1 visit (in-person) at the end of follow-up

Treatment Details

Interventions

• OnabotulinumtoxinA (Neuromuscular Blocker)

Trial Overview The trial is testing OnabotulinumtoxinA (Botox) against a saline solution (placebo). Participants will be randomly assigned to receive either Botox or placebo in a controlled setting to compare effectiveness.

Participant Groups

Group I: OnabotulinumtoxinA Experimental Treatment 1 Intervention

Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.

Group II: Saline Placebo Group 1 Intervention

The same procedure will be followed as above, but saline will be injected instead of onabotA

OnabotulinumtoxinA is already approved in Canada for the following indications:

Approved in Canada as Botox for:

• Chronic migraine
• Involuntary muscle contractions or twitching
• Excessive sweating
• Increased saliva
• Overactive bladder
• Urinary incontinence
• Facial wrinkles
• Cervical dystonia
• Upper limb spasticity
• Lower limb spasticity

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Meredith Barad Stanford, CA

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2527

Patients Recruited

17,430,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of botulinum therapy of trigeminal neuralgia]. Mingazova, LR., Orlova, OR., Soiher, MI., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute treatment of trigeminal neuralgia with onabotulinum toxin A. Zúñiga, C., Piedimonte, F., Díaz, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of multiple sclerosis-related trigeminal neuralgia with onabotulinumtoxinA. Asan, F., Gündüz, A., Tütüncü, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open study of botulinum-A toxin treatment of trigeminal neuralgia. Piovesan, EJ., Teive, HG., Kowacs, PA., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of botulinum toxin type A in trigeminal neuralgia. Zúñiga, C., Díaz, S., Piedimonte, F., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy and safety of botulinum toxin type A in trigeminal neuralgia: a systematic review. Hu, Y., Guan, X., Fan, L., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effect of Botulinum toxin-A in 88 patients with trigeminal neuralgia with 14-month follow-up. Li, S., Lian, YJ., Chen, Y., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of therapeutic effectiveness and safety of botulinum toxin type A in the treatment of idiopathic trigeminal neuralgia in patients older than 70 years]. Xu, Y., Zhang, Q., Mao, C., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of the safety and tolerability of onabotulinumtoxinA in the treatment of chronic migraine. Diener, HC., Dodick, DW., Turkel, CC., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin in the treatment of trigeminal neuralgia: 6-Month follow-up. Türk Börü, Ü., Duman, A., Bölük, C., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Botulinum Toxin Type A in Trigeminal Neuralgia in a South Asian Cohort. Caldera, MC., Senanayake, SJ., Perera, SP., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum Toxin as Monotherapy in Symptomatic Trigeminal Neuralgia. Lunde, HM., Torkildsen, Ø., Bø, L., et al.[2022]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The effectiveness of botulinum therapy of trigeminal neuralgia]. [2021]

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

Acute treatment of trigeminal neuralgia with onabotulinum toxin A. [2022]

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

Treatment of multiple sclerosis-related trigeminal neuralgia with onabotulinumtoxinA. [2023]

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

An open study of botulinum-A toxin treatment of trigeminal neuralgia. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Beneficial effects of botulinum toxin type A in trigeminal neuralgia. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy and safety of botulinum toxin type A in trigeminal neuralgia: a systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Therapeutic effect of Botulinum toxin-A in 88 patients with trigeminal neuralgia with 14-month follow-up. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Evaluation of therapeutic effectiveness and safety of botulinum toxin type A in the treatment of idiopathic trigeminal neuralgia in patients older than 70 years]. [2018]

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

Pooled analysis of the safety and tolerability of onabotulinumtoxinA in the treatment of chronic migraine. [2021]

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

Botulinum toxin in the treatment of trigeminal neuralgia: 6-Month follow-up. [2021]

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

Efficacy of Botulinum Toxin Type A in Trigeminal Neuralgia in a South Asian Cohort. [2022]

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

Botulinum Toxin as Monotherapy in Symptomatic Trigeminal Neuralgia. [2022]