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临床试验/NCT06849219
NCT06849219进行中(未招募)4 期

Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia in Patients Presenting in Outpatient Department of Neurology in Jinnah Postgraduate Medical Centre

Jinnah Postgraduate Medical Centre1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2024年9月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
122
试验地点
1
主要终点
Improvement in pain scores

研究概览

简要总结

Trigeminal neuralgia is a debilitating neurological condition, affecting quality of life in most affected patients. Carbamazepine has traditionally been used for the management of this condition, but it has a moderate effectiveness and a poor side-effect profile. Oxcarbazepine is more tolerable, and has a more favorable side-effect profile. This study aims to compare the effectiveness of oxcarbazepine and carbamazepine in the management of this condition, for improved prescription practices in the future.

详细描述

INTRODUCTION:

According to the International Headache Society, Trigeminal neuralgia is defined as "a disorder characterized by recurrent unilateral brief electric shock-like pain, abrupt in onset and termination, limited to the distribution of one or more divisions of the trigeminal nerve and triggered by innocuous stimuli" [1]. The trigeminal nerve (V) is the fifth and largest of all cranial nerves, and it is responsible for detecting sensory stimuli that arise from the craniofacial area including the forehead, cheek, and lower jaw [2]. It is a highly debilitating disorder that impacts on basic human functions such as talking, eating, drinking and touching the face, thereby resulting in a poor quality of life [3, 4].

Trigeminal neuralgia is considered a rare condition, affecting 4 to 13 people per 100,000 people annually. Women are more commonly affected than men. The female-to-male prevalence ratio ranges from 1.5 to 1.7 to 1. Most cases of trigeminal neuralgia occur after age 50, but the disease may be seen in the second and third decades of life; trigeminal neuralgia is rarely diagnosed in childhood. The lifetime prevalence of trigeminal neuralgia in population-based studies is estimated at 0.16% to 0.3% [5, 6]. A Pakistani study by Usman J, et al. audited the trigeminal neuralgia patients visiting the tertiary care hospital over a period of two years and reported a 0.46% prevalence of trigeminal neuralgia [7].

Trigeminal neuralgia is usually suspected through historical, physical and clinical examination findings. These patients should undergo neuroimaging with magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) whenever possible for confirmation of trigeminal neuralgia [6, 8, 9]. Medical therapy is the preferred initial therapeutic intervention for patients with trigeminal neuralgia. The antiepileptics carbamazepine or oxcarbazepine are the preferred initial therapeutic agents [10]. Carbamazepine is FDA indicated for epilepsy, trigeminal neuralgia, and acute manic and mixed episodes in bipolar I disorder [11]. Oxcarbazepine is an analogue of carbamazepine and is often used in acute orofacial pain episodes lasting seconds, as well as in the trigeminal nerve and its branches. Oxcarbazepine is preferred over carbamazepine because it has advantages over carbamazepine and lesser negative effects [12]. A study by Iqbal S, et al was conducted on efficacy of carbamazepine and oxcarbazepine for treating trigeminal neuralgia and reported a complete response in 42.9% of patients with carbamazepine and 67.9% of patients with oxcarbazepine. Frequency of adverse effects was higher for carbamazepine as that of Oxcarbazepine. i.e. 35.7% vs. 14.3% [13]. Another study by Di Stefano G, et al. reported that the initial proportion of responders was 88.3% with carbamazepine, and 90.9% with oxcarbazepine. Side effects occurred more frequently in patients treated with carbamazepine (43.6%) than with oxcarbazepine (30.3%) [14].

The rationale of the study is to compare the efficacy of oxcarbazepine and carbamazepine in the management of trigeminal neuralgia in patients presenting in the outpatient department of neurology at Jinnah Postgraduate Medical Centre. International and local data is very scarce regarding the comparisons of both of these drugs for treating trigeminal neuralgia. However, the effects of these drugs have been documented in the literature in comparison to other drugs or as a triple therapy combination. So, taking both drugs as monotherapy for treating trigeminal neuralgia can lead us to conclude which drug is superior as a monotherapy so that, in the future, drug with better efficacy will be preferred. The results of the study will be helpful in the selection of an appropriate and more effective drug for the treatment of trigeminal neuralgia.

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
Single (Participant)

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either gender (male or female)
  • Patients of age 25-80 years
  • Patients presenting with trigeminal neuralgia of any frequency and severity (according to operational definition) for six months
  • Patients not already receiving carbamazepine or oxcarbazepine for the management of trigeminal neuralgia

排除标准

  • Patients who have undergone any surgical procedure for the treatment of trigeminal neuralgia
  • Patients with renal and hepatic issue such as chronic renal failure and chronic liver disease
  • Patients not already receiving carbamazepine or oxcarbazepine for the management of trigeminal neuralgia
  • Patients with seizures
  • Patients who are intolerant to and allergic to both treatment drugs (oxcarbazepine and carbamazepine)
  • Pregnant and Iactating mothers
  • Patients who are not willing to participate in the study

研究组 & 干预措施

Oxcarbazepine (Group A)

Experimental

Starting dose of oxcarbazepine 150 mg BD, titrated up if no pain relief

干预措施: Oxcarbazepine (Drug)

Carbamazepine (Group B)

Active Comparator

Starting dose of carbamazepine 100 mg BD, titrated up if no relief

干预措施: Carbamazepine (Drug)

结局指标

主要结局

Improvement in pain scores

时间窗: 6 months

Visual analog scale (score from 0 to 10, where 10 indicates worst pain)

次要结局

  • Adverse effects of drugs in both arms(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Rizwana Malahat Ahmad

Postgraduate Trainee

Jinnah Postgraduate Medical Centre

研究点 (1)

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