Efficacy and Safety of Oral Antiviral Therapy for Idiopathic Trigeminal Neuralgia

Официальное название

Efficacy and Safety of Oral Antiviral Drug Combined With Carbamazepine Versus Celecoxib Combined With Carbamazepine in the Treatment of Idiopathic Trigeminal Neuralgia: A Multicenter, Randomized Controlled Trial

Обзор

This is a multicenter, prospective, randomized, controlled trial. A total of 165 patients with idiopathic trigeminal neuralgia will be enrolled and randomly divided into three groups at a 1:1:1 ratio. The aim is to compare the efficacy and safety of conventional carbamazepine monotherapy, carbamazepine combined with oral antiviral therapy, and carbamazepine combined with anti-inflammatory therapy in pain relief, quality of life improvement and adverse event profiles.

Подробное описание

Idiopathic trigeminal neuralgia is a severe neuropathic pain disorder. Carbamazepine is the first-line conventional treatment, but some patients have insufficient pain relief or intolerable side effects. Viral latent infection and neuroinflammation are considered potential pathogenesis of trigeminal neuralgia. This study intends to explore whether adding oral antiviral agent (acyclovir) or non-steroidal anti-inflammatory drug (celecoxib) can further improve pain control, reduce carbamazepine consumption, improve mood status and quality of life, and ensure clinical safety. All participants will receive 12-week standardized treatment and follow-up at 1 week, 2 weeks, 1 month, 3 months and 6 months after enrollment.

Вмешательства

• Препарат Intervention：Drug: Carbamazepine
  ArmA Dosage：Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks.
• Препарат Intervention：Drug: Carbamazepine + Acyclovir
  ArmB Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.
• Препарат Intervention：Drug: Carbamazepine + Celecoxib
  Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.

Первичные конечные точки

• Changes in Visual Analogue Scale (VAS) Pain Score [Срок оценки: Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment]

Вторичные конечные точки (4)

• Quality of Life (SF-36) Score [Срок оценки: 1 week, 2 weeks, 1 month, 3 months]
• Anxiety and Depression Score (HADS) [Срок оценки: 1 week, 2 weeks, 1 month, 3 months]
• Average Daily Carbamazepine Consumption [Срок оценки: 1 week, 2 weeks, 1 month, 3 months]
• Adverse Event Incidence [Срок оценки: Throughout 12-week treatment and follow-up period]

Критерии участия

Критерии включения

• Diagnosed with idiopathic trigeminal neuralgia according to standard clinical criteria.
• No secondary etiology confirmed by cranial imaging.
• No severe systemic disease or immune system disease.
• Voluntary participation and signed informed consent.

Критерии исключения

• Secondary trigeminal neuralgia of any cause.
• Active herpes zoster infection recently.
• Severe hepatic or renal insufficiency or contraindications to study drugs.
• Unable to complete questionnaire evaluation independently.
• Pregnancy or lactation state. -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07673549 · KY2026-126-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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