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

NCT07252453 | Active Not Recruiting DMC

• 1 other identifier: IRB/KMDC/KMU/128/2025
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trigeminal Neuralgia

Keywords

TGN; carbamazepine; oxcarbazepine

Outcome Measures

Primary Outcomes (1)

• Pain relief for TGN

  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 Outcomes (1)

• Side effects

  Two months

Study Arms (2)

Carbamazepine group

ACTIVE COMPARATOR

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

Drug: Carbamazepine

Oxcarbazepine group

ACTIVE COMPARATOR

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

Drug: oxcarbazepine

Interventions

Carbamazepine 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.

Carbamazepine group

oxcarbazepine 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

Oxcarbazepine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbasi Shaheed Hospital: lead

Study Sites (1)

Abbassi Shaheed hospital Facio-Maxillary Department

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (1)

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

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Carbamazepine; Oxcarbazepine

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr.SUFYAN AHMED, FCPS

  KARACHI METROPOLITAN UNIVERSITY/ ABBASI SHAHEED HOSPITAL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident (PG R3)

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 26, 2025
• Study Start: May 20, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: As soon as the article will get published , probably from next year (2027)
• Access Criteria: PUBLIC

Locations

PA (1)