Health TrialsbyHealthPanel

Efficacy and Safety of Oral Antiviral Therapy for Idiopathic Trigeminal Neuralgia

ConditionIdiopathic Trigeminal Neuralgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: Arm A：Control Group（Carbamazepine Monotherapy）Other 1 intervention
Group B: Arm B：Antiviral Combination Group（Carbamazepine + Acyclovir）Experimental treatment 1 intervention
Group C: Arm C：Anti-inflammatory Combination Group（Carbamazepine + Celecoxib）Experimental treatment 1 intervention

Trial outcomes

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.

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Beijing Sanbo Brain Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: