5% Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia

NCT04570293 | Completed Phase 4 DMC

• 1 other identifier: KY 2020-102-02
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Trigeminal Neuralgia

Keywords

5% Lidocaine-medicated Plaster; Trigeminal Neuralgia; Enriched Enrollment Randomized Withdrawal; Triggers

Outcome Measures

Primary Outcomes (1)

• the number of treatment failures on LMP vs. number of treatment failures on vehicle patches throughout the double-blind treatment phase

  Patients will be defined as treatment failure at the end of the double-blind treatment phase or premature discontinuation if one of the following situations occurs: * A 50% or more increase in mean daily pain intensity experienced in the paroxysms within 7-day period of double-blind treatment phase compared to that at the end of initial open-label treatment phase. * A 50% or more increase in the total number of paroxysms within 7-day period of double-blind treatment phase compared to that at the end of initial open-label treatment phase. * The patient discontinues intervention due to lack of efficacy or intolerable side effects associated study patches.

  Through study completion, an average of 7 weeks.

Secondary Outcomes (12)

• Time to loss of therapeutic response (LTR)

  During the double-blind phase after randomization, an average of 7weeks.

• Proportion of responders and non-responders

  Through the open-label period, an average of 3 weeks.

• the proportion of the patients who report pain relief of 50% or greater

  At 3 weeks, 7 weeks

• The pain intensity

  Through study completion, an average of 7 weeks.

• The number of paroxysms

  Through study completion, an average of 7 weeks.

Study Arms (2)

The LMP group

EXPERIMENTAL

The LMP group will receive lidocaine patches (active patches) measuring 10 cm x 14 cm contains 700 mg lidocaine (5% w/w).

Drug: 5% lidocaine medicated plaster

The control group

PLACEBO COMPARATOR

The control group will receive vehicle patches that are identical to the active patch, except for the absence of lidocaine, without any optical differences.

Drug: vehicle plaster

Interventions

5% lidocaine medicated plaster DRUG

The 5% lidocaine medicated plaster is measuring 10 cm x 14 cm contains 700 mg lidocaine (5% w/w) For each patient, the painful area and the trigger point will be chosen for treatment. The investigator will instruct the patient to replace the patch every 12 hours. The patches could be applied during the night (application in the evening and removal in the morning), or during the day. Patients will be told to apply up to three patches at one time.

The LMP group

vehicle plaster DRUG

Vehicle patches are identical to the active patch, except for the absence of lidocaine, without any optical differences.For each patient, the painful area and the trigger point will be chosen for treatment. The investigator will instruct the patient to replace the patch every 12 hours. The patches could be applied during the night (application in the evening and removal in the morning), or during the day. Patients will be told to apply up to three patches at one time.

The control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Occurrence of episodes of intense facial paroxysmal pain in the distribution(s) of one or more divisions of the trigeminal nerve, triggered by innocuous stimuli;
• Average daily pain intensity ≥ 4 by a brief pain inventory-short form (BPI-SF) Item 5 score (0-10 rating scale of average pain) in the preceding 24-hour period;
• Concomitant analgesic regimens that include 14 days of stable doses with systemic analgesics rather than topical agents for relief of PHN will be permitted
• Normal neurologic examination;
• Normal neuroimaging analysis.

You may not qualify if:

• Atypical pain location (eg, no specific trigger points) or trigger zones in the mouth;
• Proposed surgical intervention due to preference of the patient;
• Any condition known to interfere with the correct execution of the sensory tests (eg, peripheral or central neurological dysfunction or cognitive impairments);
• Presence of any other acute or chronic pain disorder with the need of systemic analgesic medication for more than 10 days in the last 3 months;
• Inability to discontinue the use of another lidocaine-containing products or a class I anti-arrhythmic drug during the study period;
• History of hypersensitivity to an amide-type local anesthetic agent, or other contents of the lidocaine or vehicle patch;
• History of surgical intervention or neurological ablation to treatment TN;
• Participation in another clinical trial within 30 days of the study;
• Any patient who was judged to be unreliable or unable to understand the protocol procedures;
• Any abnormality of the skin or of vascular origin at application site;
• Pregnancy or breastfeeding;.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (5)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing China-Janpan Friendship Hospital

Beijing, China

Location

Sanbo Brain Hospital, Capital Medical University

Beijing, China

Location

Jilin province people's hospital

Jilin, China

Location

Linfen People's Hospital

Shanxi, China

Location

Related Publications (6)

• 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.

  PMID: 28708009 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.

  PMID: 32413700 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.

  PMID: 19142669 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.

  PMID: 12616661 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.

  PMID: 25070398 BACKGROUND

• 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.

  PMID: 34341037 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Fang Luo

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 30, 2020
• Study Start: May 1, 2021
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (5)