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Clinical Trial NCT06849219 for Trigeminal Neuralgia is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia Phase 4 122
Clinical Trial NCT06849219 is designed to study Treatment for Trigeminal Neuralgia. It is a Phase 4 interventional study that is active, not recruiting, having started on 21 September 2024, with plans to enroll 122 participants. Led by Jinnah Postgraduate Medical Centre, it is expected to complete by 21 March 2025. The latest data from ClinicalTrials.gov was last updated on 4 March 2025.
Brief Summary
Trigeminal neuralgia is a debilitating neurological condition, affecting quality of life in most affected patients. Carbamazepine has traditionally been used for the management of this condition, but it has a moderate effectiveness and a poor side-effect profile. Oxcarbazepine is more tolerable, and has a more favorable side-effect profile. This study aims to compare the effectiveness of oxcarbazepine and carbamazepi...Show More
Detailed Description
INTRODUCTION:
According to the International Headache Society, Trigeminal neuralgia is defined as "a disorder characterized by recurrent unilateral brief electric shock-like pain, abrupt in onset and termination, limited to the distribution of one or more divisions of the trigeminal nerve and triggered by innocuous stimuli" \[1\]. The trigeminal nerve (V) is the fifth and largest of all cranial nerves, and it is res...
Show MoreOfficial Title
Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia in Patients Presenting in Outpatient Department of Neurology in Jinnah Postgraduate Medical Centre
Conditions
Trigeminal NeuralgiaOther Study IDs
- NO.F.2-81/2024-GENL/77/JPMC
NCT ID Number
Start Date (Actual)
2024-09-21
Last Update Posted
2025-03-04
Completion Date (Estimated)
2025-03-21
Enrollment (Estimated)
122
Study Type
Interventional
PHASE
Phase 4
Status
Active, not recruiting
Keywords
Trigeminal neuralgia
Carbamazepine
Oxcarbazepine
Carbamazepine
Oxcarbazepine
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalOxcarbazepine (Group A) Starting dose of oxcarbazepine 150 mg BD, titrated up if no pain relief | Oxcarbazepine Oxcarbazepine will be started at a dose of 150 mg BD, and follow-up will be done every month. Dose will be titrated up if minimal pain relief, to a maximum dose of 1800 mg per day. |
Active ComparatorCarbamazepine (Group B) Starting dose of carbamazepine 100 mg BD, titrated up if no relief | Carbamazepine Carbamazepine will be started at a dose of 100 mg BD, and follow-up will be done every month. Dose will be titrated up if minimal pain relief, to a maximum dose of 1200 mg per day. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Improvement in pain scores | Visual analog scale (score from 0 to 10, where 10 indicates worst pain) | 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Adverse effects of drugs in both arms | Common side-effects will be asked about at every visit | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
All
- Patients of either gender (male or female)
- Patients of age 25-80 years
- Patients presenting with trigeminal neuralgia of any frequency and severity (according to operational definition) for six months
- Patients not already receiving carbamazepine or oxcarbazepine for the management of trigeminal neuralgia
- Patients who have undergone any surgical procedure for the treatment of trigeminal neuralgia
- Patients with renal and hepatic issue such as chronic renal failure and chronic liver disease
- Patients not already receiving carbamazepine or oxcarbazepine for the management of trigeminal neuralgia
- Patients with seizures
- Patients who are intolerant to and allergic to both treatment drugs (oxcarbazepine and carbamazepine)
- Pregnant and Iactating mothers
- Patients who are not willing to participate in the study
Jinnah Postgraduate Medical CentreStudy Responsible Party
Rizwana Malahat Ahmad, Principal Investigator, Postgraduate Trainee, Jinnah Postgraduate Medical Centre
No contact data.
1 Study Locations in 1 Countries
Sindh
Jinnah Postgraduate Medical Centre, Karachi, Sindh, 75510, Pakistan