Idiopathic Trigeminal NeuralgiaANT-TNNCT07673549
Efficacy and Safety of Oral Antiviral Therapy for Idiopathic Trigeminal Neuralgia
A study testing Intervention：Drug: Carbamazepine, Intervention：Drug: Carbamazepine + Acyclovir and Intervention：Drug: Carbamazepine + Celecoxib in people with Idiopathic Trigeminal Neuralgia, run by Beijing Tiantan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Trigeminal Neuralgia
- What is being tested?
- Intervention：Drug: Carbamazepine, Intervention：Drug: Carbamazepine + Acyclovir and Intervention：Drug: Carbamazepine + Celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Idiopathic Trigeminal Neuralgia
- Being tested
- Intervention：Drug: Carbamazepine, Intervention：Drug: Carbamazepine + Acyclovir, Intervention：Drug: Carbamazepine + Celecoxib
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention：Drug: CarbamazepineDrug
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 + AcyclovirDrug
ArmB Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.
Intervention：Drug: Carbamazepine + CelecoxibDrug
Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Intervention：Drug: Carbamazepine + Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment
Secondary outcomes (4)
Quality of Life (SF-36) Score
Measured: 1 week, 2 weeks, 1 month, 3 months
Anxiety and Depression Score (HADS)
Measured: 1 week, 2 weeks, 1 month, 3 months
Average Daily Carbamazepine Consumption
Measured: 1 week, 2 weeks, 1 month, 3 months
Adverse Event Incidence
Measured: Throughout 12-week treatment and follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Sanbo Brain Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673549
- Sponsor's protocol ID
- KY2026-126-03
- Acronym
- ANT-TN
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly due to institutional data privacy regulations and patient confidentiality requirements. Data availability is limited to the research team and authorized institutional review personnel only.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07673549
- Acronym / sponsor ID
- ANT-TN / KY2026-126-03
- Conditions
- Idiopathic Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Sanbo Brain Hospital
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A：Control Group（Carbamazepine Monotherapy） | Other | Drug: Intervention：Drug: CarbamazepineIntervention：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. |
| Arm B：Antiviral Combination Group（Carbamazepine + Acyclovir） | Experimental | Drug: Intervention：Drug: Carbamazepine + AcyclovirIntervention：Drug: Carbamazepine + Acyclovir Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks. |
| Arm C：Anti-inflammatory Combination Group（Carbamazepine + Celecoxib） | Experimental | Drug: Intervention：Drug: Carbamazepine + CelecoxibIntervention：Drug: Carbamazepine + Celecoxib Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention：Drug: CarbamazepineArmA Dosage：Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks. | Drug | Arm A：Control Group（Carbamazepine Monotherapy） |
| Intervention：Drug: Carbamazepine + AcyclovirArmB Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks. | Drug | Arm B：Antiviral Combination Group（Carbamazepine + Acyclovir） |
| Intervention：Drug: Carbamazepine + CelecoxibDosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks. | Drug | Arm C：Anti-inflammatory Combination Group（Carbamazepine + Celecoxib） |
Primary outcome
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.
4 secondary outcomes
Quality of Life (SF-36) Score
Time frame: 1 week, 2 weeks, 1 month, 3 months
Anxiety and Depression Score (HADS)
Time frame: 1 week, 2 weeks, 1 month, 3 months
Average Daily Carbamazepine Consumption
Time frame: 1 week, 2 weeks, 1 month, 3 months
Adverse Event Incidence
Time frame: Throughout 12-week treatment and follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly due to institutional data privacy regulations and patient confidentiality requirements. Data availability is limited to the research team and authorized institutional review personnel only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention：Drug: Carbamazepine, Intervention：Drug: Carbamazepine + Acyclovir and Intervention：Drug: Carbamazepine + Celecoxib in people with Idiopathic Trigeminal Neuralgia, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianying Li tyli, doctor (+86-15560392365, Litypacop@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Visual Analogue Scale (VAS) Pain Score (time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.