To Evaluate Efficacy of Monotherapy of Oxcarbazepine Versus Combination of Gabapentin With Oxcarb… (NCT07625410) | Clinical Trial Compass
CompletedPhase 2/3
To Evaluate Efficacy of Monotherapy of Oxcarbazepine Versus Combination of Gabapentin With Oxcarbazepine in the Management of Trigeminal Neuralgia
Pakistan44 participantsStarted 2023-05-01
Plain-language summary
ABSTRACT:
Objective: This study evaluates the effectiveness of oxcarbazepine monotherapy with the combination of gabapentin and oxcarbazepine in managing trigeminal neuralgia(TN).
Methods: A prospective observational study was conducted at Rehman College of Dentistry for the duration of one year, i.e., from 1st May 2023 till May 2024. A total of 44 patients, fulfilling inclusion criteria, were included.Half were given monotherapy with oxcarbazepine (300 mg twice daily) and half were given combination therapy with gabapentin (100 mg daily) plus oxcarbazepine. Pain was evaluated utilizing the Visual Analogue Scale (VAS) at baseline, 2 weeks, and 2 months. SPSS software version 26 was used for statistical analysis.
KEYWORDS: Combination Therapy, Gabapentin, Monotherapy, Oxcarbazepine, Trigeminal Neuralgia, Visual Analogue Scale.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of either gender aged 20-80 years
* Patients presenting to the Outpatient Department (OPD)
* Patients fulfilling the diagnostic criteria for idiopathic trigeminal neuralgia according to the International Headache Society (IHS)
Exclusion Criteria:
* Patients with orofacial or odontogenic pain conditions other than trigeminal neuralgia (TN)
* Patients with temporomandibular joint (TMJ) disorders
* Patients with a centralized cause of TN evident on MRI
* Patients unwilling to participate in the study
* Patients who failed to attend follow-up visits
* Pregnant or lactating females
* Patients with a history of previous surgical procedures for neuralgia
* Patients with known allergy to medications used for neuralgia
* Patients with significant comorbid medical conditions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Scores Assessed by Visual Analog Scale (VAS)
Timeframe: Baseline, 2 weeks, and 2 months after initiation of treatment