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Trigeminal NeuralgiaPhase 4NCT06216886

OnabotulinumtoxinA for Trigeminal Neuralgia

A Phase 4 study testing OnabotulinumtoxinA 100 UNT [Botox] and Sodium Chloride 0.9% for Injection, Preservative Free in people with Trigeminal Neuralgia, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trigeminal Neuralgia
What is being tested?
OnabotulinumtoxinA 100 UNT [Botox] and Sodium Chloride 0.9% for Injection, Preservative Free
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Jun 2024to 1 Sep 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Meredith Barad, MD contact

6507217218

nlariyos@stanford.edu

Natali Ariyoshi contact

6504978821

nlariyos@stanford.edu

United States1 site, 1 recruiting

  • Meredith Barad

    Stanford, California, 94304

    Meredith Study Team, 650-721-7218, mbarad@stanford.edu

    Meredith Barad, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
OnabotulinumtoxinA 100 UNT [Botox], Sodium Chloride 0.9% for Injection, Preservative Free
Keywords
botox, injection, trigeminal neuralgia
Medical subject headings
Trigeminal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OnabotulinumtoxinA 100 UNT [Botox]Drug

    Also called 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.

  • Sodium Chloride 0.9% for Injection, Preservative FreeDrug

    Also called Saline

    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.

Study groups in NCT06216886
Study groupRoleWhat they receive
OnabotulinumtoxinAExperimentalIntradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.
Receives: Drug: OnabotulinumtoxinA 100 UNT [Botox]
SalinePlacebo comparatorThe same procedure will be followed as above, but saline will be injected instead of onabotA
Receives: Drug: Sodium Chloride 0.9% for Injection, Preservative Free

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Number of TN Attacks per week

    Frequency of TN attacks before and after onabotA injection over a seven day period

    Measured: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))

Secondary outcomes (5)

  1. Change in PROMIS Computer Adaptive Tests (PROMIS PROFILE CAT V1.0 -29)

    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.

    Measured: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)

  2. Change in Severity of Attacks Based using the numerical rating scale (NRS)

    Average severity of attack over a 7 day period

    Measured: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)

  3. Change In Baseline Pain Average using the numerical rating scale (NRS)

    baseline pain average over a seven day period

    Measured: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)

  4. Change In Acute Medication Use

    Number of doses of any acute medication use over a 7 day period

    Measured: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)

  5. Change In Patient Global Impression of Change

    A single self administered question given at week 4

    Measured: week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a randomized controlled trial of onabotulinumtoxinA versus Saline intradermal injections into the affected trigeminal distributions. The RCT will be enriched with all participants being initial responders to a preliminary round of onatbotulinumtoxinA.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06216886
Sponsor's protocol ID
66036
Status last verified
Jan 2026
First submitted
11 Jan 2024
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • undefined

  • Morra ME, Elgebaly A, Elmaraezy A, Khalil AM, Altibi AM, Vu TL, Mostafa MR, Huy NT, Hirayama K. Therapeutic efficacy and safety of Botulinum Toxin A Therapy in Trigeminal Neuralgia: a systematic review and meta-analysis of randomized controlled trials. J Headache Pain. 2016 Dec;17(1):63. doi: 10.1186/s10194-016-0651-8. Epub 2016 Jul 5.

    PubMed 27377706

  • Wei J, Zhu X, Yang G, Shen J, Xie P, Zuo X, Xia L, Han Q, Zhao Y. The efficacy and safety of botulinum toxin type A in treatment of trigeminal neuralgia and peripheral neuropathic pain: A meta-analysis of randomized controlled trials. Brain Behav. 2019 Oct;9(10):e01409. doi: 10.1002/brb3.1409. Epub 2019 Sep 21.

    PubMed 31541518

  • Hu Y, Guan X, Fan L, Li M, Liao Y, Nie Z, Jin L. Therapeutic efficacy and safety of botulinum toxin type A in trigeminal neuralgia: a systematic review. J Headache Pain. 2013 Aug 21;14(1):72. doi: 10.1186/1129-2377-14-72.

    PubMed 23964790

  • Li S, Lian YJ, Chen Y, Zhang HF, Ma YQ, He CH, Wu CJ, Xie NC, Zheng YK, Zhang Y. Therapeutic effect of Botulinum toxin-A in 88 patients with trigeminal neuralgia with 14-month follow-up. J Headache Pain. 2014 Jun 22;15(1):43. doi: 10.1186/1129-2377-15-43.

    PubMed 24952600

  • Zuniga C, Piedimonte F, Diaz S, Micheli F. Acute treatment of trigeminal neuralgia with onabotulinum toxin A. Clin Neuropharmacol. 2013 Sep-Oct;36(5):146-50. doi: 10.1097/WNF.0b013e31829cb60e.

    PubMed 24045604

  • Zhang H, Lian Y, Ma Y, Chen Y, He C, Xie N, Wu C. Two doses of botulinum toxin type A for the treatment of trigeminal neuralgia: observation of therapeutic effect from a randomized, double-blind, placebo-controlled trial. J Headache Pain. 2014 Sep 27;15(1):65. doi: 10.1186/1129-2377-15-65.

    PubMed 25263254

  • Shehata HS, El-Tamawy MS, Shalaby NM, Ramzy G. Botulinum toxin-type A: could it be an effective treatment option in intractable trigeminal neuralgia? J Headache Pain. 2013 Nov 19;14(1):92. doi: 10.1186/1129-2377-14-92.

    PubMed 24251833

  • Tangney T, Heydari ES, Sheldon BL, Shetty A, Argoff CE, Khazen O, Pilitsis JG. Botulinum Toxin as an Effective Treatment for Trigeminal Neuralgia in Surgical Practices. Stereotact Funct Neurosurg. 2022;100(5-6):314-320. doi: 10.1159/000526053. Epub 2022 Aug 9.

    PubMed 35944492

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OnabotulinumtoxinA 100 UNT [Botox] and Sodium Chloride 0.9% for Injection, Preservative Free in people with Trigeminal Neuralgia, run by Stanford 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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meredith Barad, MD (6507217218, nlariyos@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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))). 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 NCT06216886, which also lists 9 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 22 Jan 2026.

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