OnabotulinumtoxinA for Trigeminal Neuralgia

January 20, 2026 updated by: Meredith Barad, Stanford University

Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will offer onabotulinumtoxin A (Botox) delivered intradermally into the region of pain for the patient with trigeminal neuralgia. Should they derive benefit from the procedure (as determined by decrease in the frequency of attacks), then they will be randomized to receive either onabotulinumtoxin A or saline and followed for 3 months. This study hopes to provide strong data that this is a treatment option for patients with TN who have failed medications, but are not ready for or do not want to undergo surgery.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Recruiting
        • Meredith Barad
        • Contact:
        • Principal Investigator:
          • Meredith Barad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Men and women age 18 or older

  • Judged to be of legal competence
  • Sufficient knowledge of written and spoken English
  • Capable of attending regular in-person visits
  • Have failed/not a candidate/do not want surgery
  • Inadequate response to medication - at least 2 trials
  • Meeting ICHD criteria for Classical Trigeminal Neuralgia 13.1.1.1
  • Patients with frequency > 10 attacks per week
  • Stable dose of medications in the last 2 weeks

Exclusion Criteria:

  • Secondary or Idiopathic TN, or Painful Trigeminal Neuropathy as defined by the ICHD (13.1.1.2, 13.1.1.3, 13.1.2)
  • Pregnant or breast feeding (while it is rare that a patient will be pregnant with TN, there is not sufficient data to say definitively that onabotA is ok to use during pregnancy and nursing, it is still rated Class C)
  • Neuromuscular disease
  • On aminoglyocosides
  • Not currently enrolled in any other studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OnabotulinumtoxinA
Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.
Drug: OnabotulinumtoxinA 100 UNT [Botox]
Intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of onabotA. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.
Other Names:
  • Botox
Placebo Comparator: Saline
The same procedure will be followed as above, but saline will be injected instead of onabotA
Drug: Sodium Chloride 0.9% for Injection, Preservative Free
intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of saline. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Number of TN Attacks per week
Time Frame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))
Frequency of TN attacks before and after onabotA injection over a seven day period
compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PROMIS Computer Adaptive Tests (PROMIS PROFILE CAT V1.0 -29)
Time Frame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Computer adaptive tests (CATs) assess anxiety, depression, fatigue, pain interference, physical function, sleep disturbance and ability to participate in social roles and activities, and pain intensity.
compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Change in Severity of Attacks Based using the numerical rating scale (NRS)
Time Frame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Average severity of attack over a 7 day period
compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Change In Baseline Pain Average using the numerical rating scale (NRS)
Time Frame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
baseline pain average over a seven day period
compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Change In Acute Medication Use
Time Frame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Number of doses of any acute medication use over a 7 day period
compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Change In Patient Global Impression of Change
Time Frame: week 4
A single self administered question given at week 4
week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Meredith Barad, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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