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NCT Number: NCT07378046

The Analgesic Efficacy and Safety of Baclofen in Patients With Herpes Zoster

Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Recent attention has focused on the potential role of muscle relaxant, which can relieve skeletal muscle spasms and associated pain in acute musculoskeletal conditions. Therefore, investigators hypothesize that baclofen may effectively reduce the severity of HZ pain without significantly increasing adverse events.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Varicella Zoster Virus Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

13611326978

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Ages more than 18 years;
  • 2. Patients with onset of HZ rash less than 90 days;
  • 3. 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);
  • 4. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
  • 5. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
  • 6. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

Exclusion criteria

  • 1. History of taking baclofen;
  • 2. Patients with evidence of cutaneous or visceral dissemination of HZ infection (cutaneous dissemination is defined as more than 20 discrete lesions outside adjacent dermatomes) or ocular involvement of HZ;
  • 3. History of intolerance or hypersensitivity to any active components or excipient of the baclofen;
  • 4. History of systemic immune diseases, organ transplantation, or cancers;
  • 5. Pregnancy or breastfeeding;
  • 6. Suffering from acute or chronic pain disorders other than HZ.

Treatment and study plan

Baclofen combined conventional therapy

Drug

In the baclofen combined conventional therapy group, baclofen will be initiated at 15 mg daily. Then, based on the patient's response, the single dose can be gradually increased by 5mg each time, with a three-day interval. The maximum recommended dose is 30~75mg daily. In addition, the group will contain conventional treatment for HZ, except baclofen, including NSAIDs, opioids, antiviral drugs and so on.

Conventional therapy

Drug

In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Primary outcomes

  1. the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days.

    Time frame: At week 4 after experimental drug medication

    The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

Secondary outcomes

  1. The worst numeric rating scale score

    Time frame: at weeks 1, 2, 4, 8, and 12 after experimental drug medication

    The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

  2. Proportion of Patients Achieving Pain Reduction

    Time frame: at weeks 1, 2, 4, 8, and 12 after experimental drug medication

    The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity

  3. Proportion of patients developing postherpetic neuralgia

    Time frame: at week 12 after experimental drug medication

  4. The type of analgesics and average weekly consumption per analgesics

    Time frame: at weeks 4, 8, and 12 after experimental drug medication

  5. The 12-item Short-Form Health Survey (SF-12) score

    Time frame: at weeks 4, 8, and 12 after experimental drug medication

    The SF-12 score assesses the health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status.

  6. The Medical Outcomes Study Sleep Scale (MOS)

    Time frame: at weeks 4, 8, and 12 after experimental drug medication

    The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).

  7. Adverse events

    Time frame: Through study completion, an average of 12 weeks

    The incidence and proportion of adverse events will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

The Analgesic Efficacy and Safety of Oral Medications (Baclofen) in Patients With Herpes Zoster

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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