Comparison b/w Carbamazepine vs Oxcarbazepine in Treatment of Trigeminal Neuralgia

NCT ID: NCT07252453

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2025-12-01

Brief Summary

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In this Study investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia , Carbamazepine vs Oxcarbazepine

Detailed Description

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In this open pilot open label randomized controlled trial, Investigator is comparing the effectiveness and outcomes of two drugs used un the treatment of trigeminal neuralgia, Carbamazepine vs Oxcarbazepine , hypothesis would be that oxcarbazepine has equal or better outcomes comparatively with less side effects

Conditions

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Trigeminal Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carbamazepine group

In this group participants has been prescribed with carbamazepine which is conventional drug for trigeminal neuralgia management

Group Type ACTIVE_COMPARATOR

Carbamazepine

Intervention Type DRUG

Carbamazepine is a conventional drug used to treat trigeminal neuralgia. It primarily works by blocking voltage-gated sodium channels in nerve cells, which prevents rapid and repetitive firing of action potentials and reduces abnormal electrical activity in the brain.

Oxcarbazepine group

In this group participants has been prescribed with oxcarbazepine which is new FDA approved drug for TGN management

Group Type ACTIVE_COMPARATOR

oxcarbazepine

Intervention Type DRUG

Oxcarbazepine is comparatively new approved drug in the treatment of TGN. Oxcarbazepine is a prodrug that is rapidly converted to its active metabolite, (monohydroxy metabolite or MHD). This active form works by blocking voltage-sensitive sodium channels in the brain, which stabilizes over-excited nerve membranes and prevents the rapid spread of abnormal electrical activity

Interventions

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Carbamazepine

Carbamazepine is a conventional drug used to treat trigeminal neuralgia. It primarily works by blocking voltage-gated sodium channels in nerve cells, which prevents rapid and repetitive firing of action potentials and reduces abnormal electrical activity in the brain.

Intervention Type DRUG

oxcarbazepine

Oxcarbazepine is comparatively new approved drug in the treatment of TGN. Oxcarbazepine is a prodrug that is rapidly converted to its active metabolite, (monohydroxy metabolite or MHD). This active form works by blocking voltage-sensitive sodium channels in the brain, which stabilizes over-excited nerve membranes and prevents the rapid spread of abnormal electrical activity

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-60 years
* Either gender
* TGN diagnosis for ≥2 weeks (according to ICHD-3 criteria¹)

Exclusion Criteria

* Other cranial neuralgias
* Prior surgical treatment for TN
* Hepatic/renal dysfunction
* Epilepsy
* Pregnant/lactating women
* Drug allergy or intolerance
* \[Expanded\] Uncontrolled hypertension
* \[Expanded\] Psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbasi Shaheed Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sikandar Zaidi

Resident (PG R3)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr.SUFYAN AHMED, FCPS

Role: STUDY_CHAIR

KARACHI METROPOLITAN UNIVERSITY/ ABBASI SHAHEED HOSPITAL

Locations

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Abbassi Shaheed hospital Facio-Maxillary Department

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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1. International Headache Society. The International Classification of Headache Disorders (ICHD-3) - online edition, updated 2023. Available at: https://ichd-3.org

Reference Type BACKGROUND

Related Links

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Other Identifiers

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IRB/KMDC/KMU/128/2025

Identifier Type: -

Identifier Source: org_study_id

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