Efficacy and Safety of Oral Antiviral Therapy for Idiopathic Trigeminal Neuralgia

NCT07673549 | Not Yet Recruiting DMC

• 1 other identifier: KY2026-126-03
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Idiopathic Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• Changes in Visual Analogue Scale (VAS) Pain Score

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

  Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment

Secondary Outcomes (4)

• Quality of Life (SF-36) Score

  1 week, 2 weeks, 1 month, 3 months

• Anxiety and Depression Score (HADS)

  1 week, 2 weeks, 1 month, 3 months

• Average Daily Carbamazepine Consumption

  1 week, 2 weeks, 1 month, 3 months

• Adverse Event Incidence

  Throughout 12-week treatment and follow-up period

Study Arms (3)

Arm A：Control Group（Carbamazepine Monotherapy）

OTHER

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

Drug: Intervention：Drug: Carbamazepine

Arm B：Antiviral Combination Group（Carbamazepine + Acyclovir）

EXPERIMENTAL

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

Drug: Intervention：Drug: Carbamazepine + Acyclovir

Arm C：Anti-inflammatory Combination Group（Carbamazepine + Celecoxib）

EXPERIMENTAL

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

Drug: Intervention：Drug: Carbamazepine + Celecoxib

Interventions

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.

Arm A：Control Group（Carbamazepine Monotherapy）

Intervention：Drug: Carbamazepine + Acyclovir DRUG

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

Arm B：Antiviral Combination Group（Carbamazepine + Acyclovir）

Intervention：Drug: Carbamazepine + Celecoxib DRUG

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

Arm C：Anti-inflammatory Combination Group（Carbamazepine + Celecoxib）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Sanbo Brain Hospital: collaborator

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Acyclovir; Celecoxib

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Tianying Li tyli, doctor

CONTACT

+86-15560392365; Litypacop@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Pain Medicine

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share