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NCT Number: NCT07673549

Efficacy and Safety of Oral Antiviral Therapy for Idiopathic Trigeminal Neuralgia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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. -

Treatment and study plan

Intervention:Drug: Carbamazepine

Drug

ArmA Dosage:Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks.

Intervention:Drug: Carbamazepine + Acyclovir

Drug

ArmB Dosage:Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.

Intervention:Drug: Carbamazepine + Celecoxib

Drug

Dosage:Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.

Primary outcomes

  1. Changes in Visual Analogue Scale (VAS) Pain Score

    Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment

    Pain intensity is evaluated by VAS score. Effective pain relief is defined as a reduction of ≥50% from baseline VAS score.

Secondary outcomes

  1. Quality of Life (SF-36) Score

    Time frame: 1 week, 2 weeks, 1 month, 3 months

  2. Anxiety and Depression Score (HADS)

    Time frame: 1 week, 2 weeks, 1 month, 3 months

  3. Average Daily Carbamazepine Consumption

    Time frame: 1 week, 2 weeks, 1 month, 3 months

  4. Adverse Event Incidence

    Time frame: Throughout 12-week treatment and follow-up period

Study contacts

Contact information is provided by the study sponsor or research team.

Tianying Li tyli, doctor

CONTACT

[email protected]

+86-15560392365

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Sanbo Brain Hospital

Registry information

Official study title

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

Acronym: ANT-TN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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