An interventional study of Intervention：Drug: Carbamazepine and Intervention：Drug: Carbamazepine + Acyclovir in Idiopathic Trigeminal Neuralgia, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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.
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.
140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's planned enrollment of 165 is above the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →Beijing Tiantan Hospital is the lead sponsor of 490 studies on the registry; 294 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Intervention：Drug: Carbamazepine + Acyclovir Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.
Drug: Intervention：Drug: Carbamazepine + Acyclovir
Intervention：Drug: Carbamazepine + Celecoxib Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.
Drug: Intervention：Drug: Carbamazepine + Celecoxib
ArmA Dosage：Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks.
ArmB Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.
Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.
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.
Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment
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
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 33 non-industry interventional studies with no phase under Trigeminal Neuralgia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 16 months is below that.
Counting every sponsor, half of 33 studies reached it within 27 months; a quarter within 11 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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