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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
226
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.
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.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Beijing China-Janpan Friendship Hospital
Beijing, China
Sanbo Brain Hospital, Capital Medical University
Beijing, China
Jilin province people's hospital
Jilin, China
Linfen People's Hospital
Shanxi, China
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.
Time frame: Through study completion, an average of 7 weeks.
Time to loss of therapeutic response (LTR)
LTR will be defined as number of days to treatment failure in the double-blind phase after randomization.
Time frame: During the double-blind phase after randomization, an average of 7weeks.
Proportion of responders and non-responders
A responder at the end of the open-label treatment phase will be defined as follows: * A 30% or more decrease in mean daily pain intensity for the 7 days prior to Day 21 compared to that in the baseline phase while the LMP is applied and pain will return or increase when LMP is removed. * A 30% or more decrease in the total number of paroxysms for the 7 days prior to Day 21 compared to that in the baseline phase. * Regular plaster use will be defined as the plaster are applied every two days. * In addition, no intolerable side effects occur at the dose of the existing patch.
Time frame: Through the open-label period, an average of 3 weeks.
the proportion of the patients who report pain relief of 50% or greater
The pain relief will be assessed by Item 8 on the BPI-SF. Patients will be asked to circle the percentage value from 0% (no relief) to 100% (complete relief) that shows how much pain relief they have achieved during the prior 24 hours at end of open-label phase, and end of double-blind phase or premature discontinuation
Time frame: At 3 weeks, 7 weeks
The pain intensity
Patients will be asked to circle the number on an 11-point Likert scale of 0 (no pain) to 10 (worst pain imaginable) that describe their worst pain (worst pain), their least pain (least pain) and their pain on average (average pain) in the previous 24 hours and how much pain they are experiencing at the time of the evaluation (pain right now).
Time frame: Through study completion, an average of 7 weeks.
The number of paroxysms
The number of paroxysms experienced in the past 4 days weekly
Time frame: Through study completion, an average of 7 weeks.
The severity of paroxysms
The severity of paroxysms experienced in the past 4 days weekly
Time frame: Through study completion, an average of 7 weeks.
Quality of life (QoL)
Pain interference with the QOL will be assessed by Items 9A-G on the BPI-SF weekly. On these items, patients will be also asked to circle the number on an 11-point Likert scale of 0 (does not interfere) to 10 (completely interferes) that describes the extent to which pain have interfered with their activities of daily living during the prior 24 hours.
Time frame: Through study completion, an average of 7 weeks.
Pittsburgh Sleep Quality Index (PSQI) at baseline, at end of open-label phase, and end of double-blind phase or premature discontinuation
Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The total scores are 21. The higher the scores mean the worse the sleep.
Time frame: At baseline, 3 weeks, 7weeks
Short form 36 health survey questionnaire (SF-36) at baseline, end of open-label phase, and end of double-blind phase or premature discontinuation
It measures health on eight multi-item dimensions, covering functional status, wellbeing, and overall evaluation of health.
Time frame: At baseline, 3 weeks, 7weeks
The cost of treatment
The total cost of all medications for TN and the cost of LMP
Time frame: Through study completion, an average of 7 weeks.
Patient Global Impression of Change (PGIC) at end of open-label phase, and end of double-blind phase or premature discontinuation
A 7-point Likert scale, where 1 = very much improved to 7 = very much worse with a value of 4 representing no change
Time frame: At 3 weeks, 7 weeks
Study blindness
Both the clinician and patient can guess whether the drug used during double-blind phase is LMP or vehicle patches.
Time frame: Through study completion, an average of 7 weeks.
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