Herpes Zoster (HZ)NCT06969417
Comparative Efficacy of Pregabalin and Lacosamide in Patients With Herpes Zoster and Post Herpetic Neuralgia
A study testing Pregabalin and Lacosamide in people with Herpes Zoster (HZ) and Post Herpetic Neuralgia (PHN), run by CMH Kharian Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Herpes Zoster (HZ), Post Herpetic Neuralgia (PHN)
- What is being tested?
- Pregabalin and Lacosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed cases of herpes zoster suffering from postherpetic neuralgia
- Ages: 18 to 50
- Both male and female
Who cannot join
- Lack of consent
- Patient already taking pain killers for post herpetic neuralgia
- Patients suffering from other systemic illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
CMH Kharian Medical College
Kharan, Punjab Province, 50070
Mushayada Irshad, MBBS, Mphil, +923237088421, info@ckmc.edu.pk
About this study
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)
- Being tested
- Pregabalin, Lacosamide
- Medical subject headings
- Herpes Zoster, Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
- Group A will receive Cap Pregabalin 150mg oral OD for 4 weeks
LacosamideDrug
- Group B will receive Tab Lacosamide 100mg oral BD for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will receive Cap Pregabalin, the first intervention Receives: Drug: Pregabalin |
| Group B | Experimental | Group B will receive Tab Lacosamide Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain intensity will be measured before and after treatment with help of Visual Analog Scale.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start10 Apr 2025
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Zoster (HZ)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMH Kharian Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mushayada Irshad, CMH Kharian Medical College
- Investigators
- Usman Nawaz, MBBS, Mphil, PhD Pharmacology, Study chair, CMH Kharian Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969417
- Sponsor's protocol ID
- CKMC/IERB/AC-00225
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision will be taken after getting consent from each participant.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Pregabalin and Lacosamide in Patients With Herpes Zoster and Post Herpetic Neuralgia
- ClinicalTrials.gov ID
- NCT06969417
- Acronym / sponsor ID
- CKMC/IERB/AC-00225
- Conditions
- Herpes Zoster (HZ), Post Herpetic Neuralgia (PHN)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CMH Kharian Medical CollegeOther government
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: PregabalinGroup A will receive Cap Pregabalin, the first intervention |
| Group B | Experimental | Drug: LacosamideGroup B will receive Tab Lacosamide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed cases of herpes zoster suffering from postherpetic neuralgia
- Ages: 18 to 50
- Both male and female
Key exclusion criteria (3 listed)
- Lack of consent
- Patient already taking pain killers for post herpetic neuralgia
- Patients suffering from other systemic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalino Group A will receive Cap Pregabalin 150mg oral OD for 4 weeks | Drug | Group A |
| Lacosamideo Group B will receive Tab Lacosamide 100mg oral BD for 4 weeks | Drug | Group B |
Primary outcome
Visual Analog Scale
Time frame: 4 weeks
Pain intensity will be measured before and after treatment with help of Visual Analog Scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided. The decision will be taken after getting consent from each participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Usman Nawaz, MBBS, Mphil, PhD Pharmacology study chair
CMH Kharian Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and Lacosamide in people with Herpes Zoster (HZ) and Post Herpetic Neuralgia (PHN), run by CMH Kharian Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mushayada Irshad, MBBS, MPhil Pharmacology (+92537532239, mishy2360@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.