OnabotulinumtoxinA for Trigeminal Neuralgia

NCT06216886 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 66036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trigeminal Neuralgia

Keywords

botox; injection; trigeminal neuralgia

Outcome Measures

Primary Outcomes (1)

• Change in Number of TN Attacks per week

  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 Outcomes (5)

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

  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)

  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)

  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

  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

  week 4

Study Arms (2)

OnabotulinumtoxinA

EXPERIMENTAL

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]

Saline

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Saline

Saline

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.

Also known as: Botox

OnabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Meredith Barad

Stanford, California, 94304, United States

RECRUITING

Related Publications (9)

• undefined

  BACKGROUND

• 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.

  PMID: 27377706 BACKGROUND

• 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.

  PMID: 31541518 BACKGROUND

• 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.

  PMID: 23964790 BACKGROUND

• 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.

  PMID: 24952600 BACKGROUND

• 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.

  PMID: 24045604 BACKGROUND

• 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.

  PMID: 25263254 BACKGROUND

• 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.

  PMID: 24251833 BACKGROUND

• 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.

  PMID: 35944492 BACKGROUND

Related Links

• NIH PROMIS MEASURES
• Quality of Life Scale instructions and References

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Botulinum Toxins, Type A; Sodium Chloride; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Meredith Barad, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith Barad, MD

CONTACT

6507217218; nlariyos@stanford.edu

Natali Ariyoshi

CONTACT

6504978821; nlariyos@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: After the initial round of botox, all participants will be randomized to either onabotA or saline. The randomization will performed by a provider who is not a care provider or proceduralist. The patient will be blinded, the proceduralist will be blinded and the care provider will be blinded. Data will be stored and not reviewed by research team until the study closes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Anesthesiology (Pain) and Neurology & Neurological Sciences

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)