The PATCH Trial: Effectiveness and Safety of 5% Lidocaine-medicated Plaster for the Treatment of Trigeminal Neuralgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 5
- 主要终点
- the number of treatment failures on LMP vs. number of treatment failures on vehicle patches throughout the double-blind treatment phase
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;.
研究组 & 干预措施
The LMP group
The LMP group will receive lidocaine patches (active patches) measuring 10 cm x 14 cm contains 700 mg lidocaine (5% w/w).
干预措施: 5% lidocaine medicated plaster (Drug)
The control group
The control group will receive vehicle patches that are identical to the active patch, except for the absence of lidocaine, without any optical differences.
干预措施: vehicle plaster (Drug)
结局指标
主要结局
the number of treatment failures on LMP vs. number of treatment failures on vehicle patches throughout the double-blind treatment phase
时间窗: Through study completion, an average of 7 weeks.
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.
次要结局
- The number of paroxysms(Through study completion, an average of 7 weeks.)
- the proportion of the patients who report pain relief of 50% or greater(At 3 weeks, 7 weeks)
- Time to loss of therapeutic response (LTR)(During the double-blind phase after randomization, an average of 7weeks.)
- Pittsburgh Sleep Quality Index (PSQI) at baseline, at end of open-label phase, and end of double-blind phase or premature discontinuation(At baseline, 3 weeks, 7weeks)
- The cost of treatment(Through study completion, an average of 7 weeks.)
- Proportion of responders and non-responders(Through the open-label period, an average of 3 weeks.)
- Short form 36 health survey questionnaire (SF-36) at baseline, end of open-label phase, and end of double-blind phase or premature discontinuation(At baseline, 3 weeks, 7weeks)
- The pain intensity(Through study completion, an average of 7 weeks.)
- The severity of paroxysms(Through study completion, an average of 7 weeks.)
- Quality of life (QoL)(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(At 3 weeks, 7 weeks)
- Study blindness(Through study completion, an average of 7 weeks.)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital