Clinical trial NCT06216886: OnabotulinumtoxinA for Trigeminal Neuralgia
Official title: Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Trigeminal Neuralgia
Keywords: botox
injection
trigeminal neuralgia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of TN Attacks per week
timeFrame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))
Secondary outcomes:
measure: Change in PROMIS Computer Adaptive Tests (PROMIS PROFILE CAT V1.0 -29)
timeFrame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
measure: Change in Severity of Attacks Based using the numerical rating scale (NRS)
timeFrame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
measure: Change In Baseline Pain Average using the numerical rating scale (NRS)
timeFrame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
measure: Change In Acute Medication Use
timeFrame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
measure: Change In Patient Global Impression of Change
timeFrame: week 4
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Meredith Barad
state: California
Study officials:
affiliation: Stanford University
name: Meredith Barad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: undefined
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.
citation: 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.
citation: 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.
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.
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.
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.
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.
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.