NCT06849219

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 carbamazepine in the management of this condition, for improved prescription practices in the future.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 23, 2025

Last Update Submit

February 27, 2025

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal neuralgiaCarbamazepineOxcarbazepine

Outcome Measures

Primary Outcomes (1)

  • Improvement in pain scores

    Visual analog scale (score from 0 to 10, where 10 indicates worst pain)

    6 months

Secondary Outcomes (1)

  • Adverse effects of drugs in both arms

    6 months

Study Arms (2)

Oxcarbazepine (Group A)

EXPERIMENTAL

Starting dose of oxcarbazepine 150 mg BD, titrated up if no pain relief

Drug: Oxcarbazepine

Carbamazepine (Group B)

ACTIVE COMPARATOR

Starting dose of carbamazepine 100 mg BD, titrated up if no relief

Drug: Carbamazepine

Interventions

OxcarbazepineDRUG

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.

Also known as: Telox, Trioptal, Oxalepsy
Oxcarbazepine (Group A)
CarbamazepineDRUG

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.

Also known as: Tegral, Seizunil, Teril
Carbamazepine (Group B)

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

OxcarbazepineCarbamazepine

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Dr. Rizwana Malahat Ahmad, MBBS

    Jinnah Postgraduate Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Trainee

Study Record Dates

First Submitted

February 23, 2025

First Posted

February 27, 2025

Study Start

September 21, 2024

Primary Completion

January 30, 2025

Study Completion

March 21, 2025

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)