To Evaluate Efficacy of Monotherapy of Oxcarbazepine Versus Combination of Gabapentin With Oxcarbazepine in the Management of Trigeminal Neuralgia

NCT07625410 | Completed Phase 2 DMC

• 2 other identifiers: RCD-04-23-167Ethical approval RCD-04-23-167
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

ABSTRACT: Objective: This study evaluates the effectiveness of oxcarbazepine monotherapy with the combination of gabapentin and oxcarbazepine in managing trigeminal neuralgia(TN). Methods: A prospective observational study was conducted at Rehman College of Dentistry for the duration of one year, i.e., from 1st May 2023 till May 2024. A total of 44 patients, fulfilling inclusion criteria, were included.Half were given monotherapy with oxcarbazepine (300 mg twice daily) and half were given combination therapy with gabapentin (100 mg daily) plus oxcarbazepine. Pain was evaluated utilizing the Visual Analogue Scale (VAS) at baseline, 2 weeks, and 2 months. SPSS software version 26 was used for statistical analysis. KEYWORDS: Combination Therapy, Gabapentin, Monotherapy, Oxcarbazepine, Trigeminal Neuralgia, Visual Analogue Scale.

Conditions

Pain; Pain Management; Effectiveness of Drugs Was Compared for Treating Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Scores Assessed by Visual Analog Scale (VAS)

  Pain intensity was assessed using the Visual Analogue Scale , a 10-cm horizontal line ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain severity (worse outcome). Participants will receive either oxcarbazepine monotherapy or combination therapy with gabapentin plus oxcarbazepine. VAS pain scores will be recorded at baseline, 2 weeks, and 2 months to evaluate changes in pain intensity over time.

  Baseline, 2 weeks, and 2 months after initiation of treatment

Study Arms (2)

Oxcarbamezapine monotherapy

ACTIVE COMPARATOR

group given monotherapy with oxcarbamezapine

Drug: oxcarbamezapine(300 mg twice daily)

Oxcarbamezapine plus gabapentine combination therapy

ACTIVE COMPARATOR

group given comination therapy(oxcarbamezapine with gabapentine)

Drug: combination therapy(oxcarbamezapine 300 mg twice daily and gabapentine)

Interventions

oxcarbamezapine(300 mg twice daily) DRUG

monotherapy with oxcarbamezapine(300 mg twice daily)

Oxcarbamezapine monotherapy

combination therapy(oxcarbamezapine 300 mg twice daily and gabapentine) DRUG

combination therapy of oxcarbamezapine with gabapentine was given

Oxcarbamezapine plus gabapentine combination therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either gender aged 20-80 years
• Patients presenting to the Outpatient Department (OPD)
• Patients fulfilling the diagnostic criteria for idiopathic trigeminal neuralgia according to the International Headache Society (IHS)

You may not qualify if:

• Patients with orofacial or odontogenic pain conditions other than trigeminal neuralgia (TN)
• Patients with temporomandibular joint (TMJ) disorders
• Patients with a centralized cause of TN evident on MRI
• Patients unwilling to participate in the study
• Patients who failed to attend follow-up visits
• Pregnant or lactating females
• Patients with a history of previous surgical procedures for neuralgia
• Patients with known allergy to medications used for neuralgia
• Patients with significant comorbid medical conditions

Sponsors & Collaborators

• Rehman Medical Institute - RMI: lead

Study Sites (1)

Rehman College of Dentistry

Peshawar, Khyber Pakhtunkhwa, 25100, Pakistan

Location

Related Publications (5)

• Cheshire WP Jr. Defining the role for gabapentin in the treatment of trigeminal neuralgia: a retrospective study. J Pain. 2002 Apr;3(2):137-42. doi: 10.1054/jpai.2002.122944.

  PMID: 14622800 BACKGROUND

• Texakalidis P, Xenos D, Tora MS, Wetzel JS, Boulis NM. Comparative safety and efficacy of percutaneous approaches for the treatment of trigeminal neuralgia: A systematic review and meta-analysis. Clin Neurol Neurosurg. 2019 Jul;182:112-122. doi: 10.1016/j.clineuro.2019.05.011. Epub 2019 May 14.

  PMID: 31121470 BACKGROUND

• Das B, Saha SP. Trigeminal neuralgia: current concepts and management. J Indian Med Assoc. 2001 Dec;99(12):704-9.

  PMID: 12022221 BACKGROUND

• Ishikawa R, Iseki M. [Pharmacological Treatment of Trigeminal Neuralgia]. No Shinkei Geka. 2024 Jan;52(1):63-69. doi: 10.11477/mf.1436204880. Japanese.

  PMID: 38246671 BACKGROUND

• Lee JY, Lee GH, Yi SH, Sim WS, Kim BW, Park HJ. Non-Surgical Treatments of Trigeminal Neuralgia from the Perspective of a Pain Physician: A Narrative Review. Biomedicines. 2023 Aug 21;11(8):2315. doi: 10.3390/biomedicines11082315.

  PMID: 37626811 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• iftikhar qayum, MBBS, MD, PHD

  Rehman Medical Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 4, 2026
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Available indefinitely
• Access Criteria: Other researchers doing similar drug trials. Access will be through email requests.

Locations

PA (1)