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

November 24, 2025 updated by: Sikandar Zaidi, Abbasi Shaheed Hospital

Comparison of Carbamazepine and Oxcarbazepine In the Treatment of Trigeminal Neuralgia

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • Abbassi Shaheed hospital Facio-Maxillary Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

  • Inclusion Criteria:

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

Exclusion Criteria [Expanded]:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Carbamazepine group
In this group participants has been prescribed with carbamazepine which is conventional drug for trigeminal neuralgia management
Drug: 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.
Active Comparator: Oxcarbazepine group
In this group participants has been prescribed with oxcarbazepine which is new FDA approved drug for TGN management
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief for TGN
Time Frame: Two months
Pain relief for Trigeminal neuralgia will be assessed define as complete resolution of symptoms (PAIN) , after prescribing both drugs to each individual group, Pain relief will be assessed using visual analogue scale (VAS SCORE) , which is designated by number 1 to 10, in which 1 means NO PAIN, and 10 means SEVERE PAIN. Annexure will be provided to each participant which includes study consent, demographic details, medical history in relevance with inclusion and exclusion criteria, side effects , LFTs values and printed Visual Analogue Scale on the very same document.
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: Two months
Side effects of each drug will be compared including hepatotoxicity through liver functional tests, and other effects including nausea tolerability, dizziness etc. Annexure will be provided to each group participants ( same as mentioned in primary outcome section) ,which includes side effects column specifically Liver Functional Test results including both baselines values ( during the start of treatment ) and final results( at the end of treatment) and comparison will be made between the two drugs regarding side effects specifically hepatotoxicity.
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbasi Shaheed Hospital

Investigators

  • Study Chair: Dr.SUFYAN AHMED, FCPS, KARACHI METROPOLITAN UNIVERSITY/ ABBASI SHAHEED HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2025

Primary Completion (Actual)

November 20, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/KMDC/KMU/128/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Primary and secondary outcomes

IPD Sharing Time Frame

As soon as the article will get published , probably from next year (2027)

IPD Sharing Access Criteria

PUBLIC

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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