OnabotulinumtoxinA for Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216886
• Other study ID #: 66036
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Meredith Barad	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Secondary	Change in Severity of Attacks Based using the numerical rating scale (NRS)	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)
Secondary	Change In Baseline Pain Average using the numerical rating scale (NRS)	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)
Secondary	Change In Acute Medication Use	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)
Secondary	Change In Patient Global Impression of Change	A single self administered question given at week 4	week 4

External Links

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