5% Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): 5% lidocaine medicated plaster; vehicle plaster
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 5% Lidocaine-medicated Plaster; Trigeminal Neuralgia; Enriched Enrollment Randomized Withdrawal; Triggers