5% Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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.