Comparative Efficacy of Pregabalin and Lacosamide in Patients With Herpes Zoster and Post Herpetic Neuralgia

NCT06969417 | Recruiting DMC

• 1 other identifier: CKMC/IERB/AC-00225
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Post-herpetic neuralgia (PHN) is the most significant complication of herpes zoster caused by reactivation of latent Varicella-Zoster virus (VZV). PHN is characterized by neuropathic pain lasting beyond the resolution of the rashes. Post herpetic neuralgia (PHN) represents a potentially debilitating and often undertreated form of neuropathic pain that disproportionately affects vulnerable populations, including the elderly and the immunocompromised. PHN pain is typically localized, unilateral and chronic, but may be constant, intermittent, spontaneous and/or evoked. PHN is likely to interfere with sleep and daily activities. Pregabalin is a gabapentinoid licenced for treatment of neurological disorders. It is one of the earlier drugs approved by the US Food and Drug Administration (2004) for the treatment of painful diabetic neuropathy and postherpetic neuralgia (PHN). Lacosamide (LCM) was approved in 2008 in the European Union and in the United States as adjunctive therapy for the treatment of focal-onset seizures with or without secondary generalization in adults and adolescents with epilepsy. Its efficacy has also been proven in neuropathic pain. Although Pregabalin and Lacosamide have proven effective in various neuropathic pain disorder, comparative studies specifically for PHN remain scarce. This study aims to compare the efficacy of Pregabalin and Lacosamide in PHN patients, addressing the current gap in literature and providing clinically relevant insights to optimize treatment selection.

Conditions

Herpes Zoster (HZ); Post Herpetic Neuralgia (PHN)

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  Pain intensity will be measured before and after treatment with help of Visual Analog Scale.

  4 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A will receive Cap Pregabalin, the first intervention

Drug: Pregabalin

Group B

EXPERIMENTAL

Group B will receive Tab Lacosamide

Drug: Lacosamide

Interventions

Pregabalin DRUG

o Group A will receive Cap Pregabalin 150mg oral OD for 4 weeks

Group A

Lacosamide DRUG

o Group B will receive Tab Lacosamide 100mg oral BD for 4 weeks

Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed cases of herpes zoster suffering from postherpetic neuralgia
• Ages: 18 to 50
• Both male and female

You may not qualify if:

• Lack of consent
• Patient already taking pain killers for post herpetic neuralgia
• Patients suffering from other systemic illness

Sponsors & Collaborators

• CMH Kharian Medical College: lead

Study Sites (1)

CMH Kharian Medical College

Kharan, Punjab Province, 50070, Pakistan

RECRUITING

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Interventions

Pregabalin; Lacosamide

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Acetamides; Amides; Acetates

Study Officials

• Usman Nawaz, MBBS, Mphil, PhD Pharmacology

  CMH Kharian Medical College

  STUDY CHAIR

Central Study Contacts

Mushayada Irshad, MBBS, MPhil Pharmacology

CONTACT

+92537532239; mishy2360@gmail.com

Muhammad Waseem Shahid, MBBS, FCPS Dermatology

CONTACT

+923347202392; waseem2392@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mushayada Irshad

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: April 10, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

PA (1)