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临床试验/NCT00913107
NCT00913107已完成2 期

Lamotrigine in Trigeminal Neuralgia: Efficacy and Safety in Comparison With Carbamazepine

University of Malaya2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
21
试验地点
2
主要终点
Pain-relief

研究概览

简要总结

The purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (TGN).

详细描述

Trigeminal Neuralgia (TGN) is a rare form of chronic facial pain shrouded in mystery, although not life threatening, can be excruciating painful and extraordinarily debilitating. Its uniqueness and peculiarity can be ascertained by the fact that TGN may present to and be managed by dentists, neurologists, neurosurgeons, oral surgeons and ear, nose and throat surgeons.

The management of TGN is initially medical, with the "gold standard" drug of carbamazepine (CBZ). Whilst CBZ continues to be the treatment of choice, a substantial proportion of patients tolerate this drug poorly, predominantly because of side-effects that include drowsiness, accommodation disorders, hepatitis, elevation in liver enzymes, renal dysfunction, congestive heart failure, delayed multi-organ failure, leucopenia, thrombocytopenia etc. etc. If pain-relief is incomplete with CBZ or it produces adverse side-effects, options include using an alternative second-line medical agent. The drugs suggested to be considered as second-line agents for the treatment of TGN, include: lamotrigine, baclofen, phenytoin, oxcarbazepine, gabapentin, clonazepam, valproate, mexiletine, and topiramate.

Lamotrigine (LTG), a novel anticonvulsant, which has not been adequately assessed for its antineuralgic properties. It has a bimodal mechanism of action:

  • inhibits the release of glutamate and aspartate by blocking voltage-sensitive sodium channels
  • antagonistic at neuroexcitatory N-methyl-d-aspartate receptors.

It can also acts at and inhibits calcium channels to enhance the gamma- Aminobutyric acid (GABA) synthesis. GABA is an inhibitory amino acid neurotransmitter that decreases neural membrane action potentials and therefore decreases nerve excitability. Glutamate has been implicated in the mechanisms contributing towards phenomenon of chronic pain, such as sensitisation and wind up. LTG through its inhibition of pathological release of glutamate, has the potential towards management of chronic pain, particularly of neuropathic origin.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Trigeminal Neuralgia
  • Male; or non-pregnant/non-lactating female
  • Must be willing to cooperate with and understands study instructions
  • Signed informed consent prior to entering study

排除标准

  • psychiatric illness
  • severe liver or cardiovascular disease
  • renal impairment, low white cell count
  • malignancy
  • pregnancy or lactation
  • alcohol or recreational drug abuse
  • and positive tests for human immunodeficiency virus or hepatitis B or C.

研究组 & 干预措施

Lamictal®

Experimental

Lamictal® was used as the "active" medication in this study.

干预措施: Lamictal® (Drug)

Lamictal®

Experimental

Lamictal® was used as the "active" medication in this study.

干预措施: Tegretol® (Drug)

Tegretol®

Active Comparator

Tegretol® was employed as the "control" for comparative purposes in order to check and evaluate the efficacy (pain-relief) and occurrence of side- effects of Lamictal®.

干预措施: Lamictal® (Drug)

Tegretol®

Active Comparator

Tegretol® was employed as the "control" for comparative purposes in order to check and evaluate the efficacy (pain-relief) and occurrence of side- effects of Lamictal®.

干预措施: Tegretol® (Drug)

结局指标

主要结局

Pain-relief

时间窗: 3-6 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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