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NCT Number: NCT06216886

OnabotulinumtoxinA for Trigeminal Neuralgia

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

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Meredith Barad

Stanford, California, 94304, United States

Location status: Recruiting

Location contact

Meredith Barad, MD

PRINCIPAL_INVESTIGATOR

Meredith Study Team

CONTACT

[email protected]

650-721-7218

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OnabotulinumtoxinA 100 UNT [Botox]

Drug

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

Sodium Chloride 0.9% for Injection, Preservative Free

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. Change In Patient Global Impression of Change

    Time frame: week 4

    A single self administered question given at week 4

Study contacts

Contact information is provided by the study sponsor or research team.

Meredith Barad, MD

CONTACT

[email protected]

6507217218

Natali Ariyoshi

CONTACT

[email protected]

6504978821

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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