OnabotulinumtoxinA for Trigeminal Neuralgia

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 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 f
• Препарат 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 fo

Первичные конечные точки

• Change in Number of TN Attacks per week [Срок оценки: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))]

Вторичные конечные точки (5)

• Change in PROMIS Computer Adaptive Tests (PROMIS PROFILE CAT V1.0 -29) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: week 4]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Meredith Barad — Stanford

Публикации

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• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06216886 · 66036

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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