The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster

NCT07361796 | Recruiting DMC

• 1 other identifier: KY2025-369-02-3
• Study Type: interventional
• Target: 832
• Locations: 1 country
• Sites: 1

Brief Summary

Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) and represents a major clinical challenge due to its chronicity and impact on quality of life. Current treatments for acute HZ pain have limited efficacy in preventing PHN, highlighting the need for effective preventive strategies targeting early pathophysiological mechanisms. Venlafaxine as a plausible and clinically relevant candidate for early intervention to prevent the transition from acute HZ pain to PHN.

Conditions

Pain; Postherpetic Neuralgia; Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• Incidence of PHN

  PHN will be defined as persistent pain in the affected dermatome at 90 days after rash onset that is clinically meaningful, operationalized as an average pain score ≥ 3 on the NRS.

  at 90 days after rash onset

Secondary Outcomes (9)

• The average daily pain intensity

  at weeks 1, 2, 4, 8, 12, 24, and 52

• The worst numeric rating scale score

  at weeks 1, 2, 4, 8, 12, 24, and 52

• Proportion of Patients Achieving Pain Reduction

  at weeks 1, 2, 4, 8, 12, 24, and 52

• Average weekly consumption of each analgesic class

  at weeks 4, 8, 12, 24, and 52

• Herpes Zoster Severity of Illness Index

  at weeks 1, 2, 4, 8 and 12

Study Arms (2)

Venlafaxine combined with conventional therapy group

EXPERIMENTAL

Drug: Venlafaxine combined conventional therapy

Conventional therapy group

ACTIVE COMPARATOR

Drug: Conventional therapy

Interventions

Conventional therapy DRUG

The control group will receive conventional therapy alone before 90 days after rash onset. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.

Conventional therapy group

Venlafaxine combined conventional therapy DRUG

Venlafaxine will be initiated at 75 mg once daily and titrated based on pain response and tolerability before 90 days after rash onset. All participants will receive standardized analgesic management following the World Health Organization pain ladder. In addition, the group will contain conventional treatment for HZ, including NSAIDs, opioids, antiviral drugs and so on. After 90 days from rash onset, treatment will be standardized across both groups. Participants who develop persistent pain consistent with PHN will receive guideline-based management, including gabapentinoids, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and topical agents such as lidocaine or capsaicin, as clinically indicated.

Venlafaxine combined with conventional therapy group

Eligibility Criteria

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

You may qualify if:

• \. Ages more than 18 years;
• \. Patients with onset of HZ rash less than 30 days;
• \. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
• \. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
• \. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
• \. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

You may not qualify if:

• \. HZ with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system involvement or generalized HZ;
• Known hypersensitivity to venlafaxine;
• History of major depressive disorder requiring antidepressant therapy;
• History of systemic immune diseases, organ transplantation, or cancers;
• Pregnancy or lactation;
• Presence of acute or chronic pain disorders other than HZ.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: collaborator
• Zhongnan Hospital: collaborator
• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

RECRUITING

Related Links

• Rosamilia LL. Herpes Zoster Presentation, Management, and Prevention: A Modern Case-Based Review. Am J Clin Dermatol. 2020;21(1):97-107.
• Liu Y, Xiao S, Li J, Long X, Zhang Y, Li X. A Network Meta-Analysis of Randomized Clinical Trials to Assess the Efficacy and Safety of Antiviral Agents for Immunocompetent Patients with Herpes Zoster-Associated Pain. Pain Physician. 2023;26(4):337-46.

MeSH Terms

Conditions

Herpes Zoster; Pain; Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fang Luo

CONTACT

13611326978; 13611326978@163.com

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: Director, Department of Pain Management, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 23, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)