5% Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
Summary
Trigeminal neuralgia (TN) is characterized by sudden, severe, usually unilateral, transient, stinging, recurrent electrocute-like shock in one or more divisions of the trigeminal nerve, lasting from a few seconds to less than 2 minutes.Simple daily-life activities, such as washing the face, brushing the teeth, eating, and talking, or the slight touch of trigger points may trigger the attack of pain of TN, resulting in a decline in the patient's quality of life (QoL). Trigger zones predominantly locate in the perioral and nasal region. Paroxysmal pain is associated with triggers in virtually all patients with TN. TN may be caused by abnormality of the trigger zone and the blockade of Na+ channel of trigger zone may be a novel and effective treatment methods for TN. Currently, most patients with TN may not achieve adequate pain relief with a single therapeutic agent. Multiple analgesics targeting different mechanisms of the pain pathway are often used.5% lidocaine medicated plaster (LMP) is a white hydrogel plaster containing adhesive material. LMP was approved for post-herpetic neuralgia (PHN) treatment by the United States Food and Drug Administration (FDA) in 1999. Tamburin et al reported that 2 patients with primary TN who stopped oral drugs because of side effects or refused surgical procedures. Both patients were instructed to wear LMP over the affected area and LMP resulted in reduction of pain intensity and the number of pain paroxysms without side effects. However, due to limitations of these open-label design studies, the observed reductions in pain intensity may have been due to treatment effect, placebo effect, changes in underlying disease state, or a combination of these factors. Therefore, randomized controlled trials will be need to be performed to draw about the efficacy of the LMP in TN. The PATCH trial is a prospective, double-blinded, vehicle-controlled, parallel-group, multicenter, enriched enrolment with randomized withdrawal (EERW) trial aimed at estimating the efficacy and safety of LMP in patients with TN. After providing informed consent and completing a baseline evaluation, patients will participate in an initial open-label treatment period of LMP (active patches). This openly titrated process is close to clinical practice and can provide data on the proportion of responders and non-responders, the optimal dose of the analgesic drug, and the proportion of withdrawal due to adverse effects. A responder at the end of the open-label treatment phase will be included in the subsequently double-blind treatment phase.
Timeline
- Start
- 2021-05-01
- Primary completion
- 2022-08-26
- Completion
- 2022-08-26
Outcome
Met primary endpoint
paper For the primary endpoint, 16 (26.0%) patients with LMP and 36 (58.0%) patients with vehicle patches met the treatment failure criteria PMID 39193836 ↗
paper relative risk, 0.48; 95% confidence interval [CI], 0.31 to 0.75; p < 0.001 PMID 39193836 ↗
Publications
- Background Di Stefano G, Maarbjerg S, Nurmikko T, Truini A, Cruccu G. Triggering trigeminal neuralgia. Cephalalgia. 2018 May;38(6):1049-1056. doi: 10.1177/0333102417721677. Epub 2017 Jul 14.
- Background Liu M, Zhong J. Mechanism underlying cranial nerve rhizopathy. Med Hypotheses. 2020 Sep;142:109801. doi: 10.1016/j.mehy.2020.109801. Epub 2020 May 6.
- Background Cheville AL, Sloan JA, Northfelt DW, Jillella AP, Wong GY, Bearden Iii JD, Liu H, Schaefer PL, Marchello BT, Christensen BJ, Loprinzi CL. Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB). Support Care Cancer. 2009 Apr;17(4):451-60. doi: 10.1007/s00520-008-0542-x. Epub 2009 Jan 13.
- Background Gammaitoni AR, Alvarez NA, Galer BS. Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. J Clin Pharmacol. 2003 Feb;43(2):111-7. doi: 10.1177/0091270002239817.
- Background Tamburin S, Schweiger V, Magrinelli F, Brugnoli MP, Zanette G, Polati E. Effect of 5% lidocaine medicated plaster on pain intensity and paroxysms in classical trigeminal neuralgia. Ann Pharmacother. 2014 Nov;48(11):1521-4. doi: 10.1177/1060028014544166. Epub 2014 Jul 28.
- Zhao C, Shrestha N, Ren H, Zhang B, Shen Y, Meng L, Wu D, Wang B, Fan B, Luo F. The PATCH trial: 5% lidocaine-medicated plaster for trigeminal neuralgia-Results of a multicentric, enriched enrollment, randomized withdrawal, double-blind, vehicle-controlled, parallel-group study. Headache. 2024 Nov-Dec;64(10):1318-1328. doi: 10.1111/head.14814. Epub 2024 Aug 28.
- Zhao C, Shrestha N, Liu H, Shen Y, Meng L, Fan B, Luo F. The PATCH trial: efficacy and safety of 5% lidocaine-medicated plaster for the treatment of patients with trigeminal neuralgia: a study protocol for a multicentric, double-blind, enriched enrolment randomised withdrawal, vehicle-controlled study. BMJ Open. 2021 Aug 2;11(8):e045493. doi: 10.1136/bmjopen-2020-045493.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 700 mg | Topical |