Menu
Recruiting NCT07378046

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

No phase Interventional Herpes Zoster Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Baclofen combined conventional therapy, Conventional therapy.
Who it may be relevant to
Registry conditions: Herpes Zoster, Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Baclofen combined conventional therapy
    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.
  • Drug Conventional therapy
    In the conventional therapy group, treatments will include NSAIDs, opioids, antiviral drugs and so on.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • The worst numeric rating scale score [Time frame: at weeks 1, 2, 4, 8, and 12 after experimental drug medication]
  • Proportion of Patients Achieving Pain Reduction [Time frame: at weeks 1, 2, 4, 8, and 12 after experimental drug medication]
  • Proportion of patients developing postherpetic neuralgia [Time frame: at week 12 after experimental drug medication]
  • The type of analgesics and average weekly consumption per analgesics [Time frame: at weeks 4, 8, and 12 after experimental drug medication]
  • The 12-item Short-Form Health Survey (SF-12) score [Time frame: at weeks 4, 8, and 12 after experimental drug medication]
  • The Medical Outcomes Study Sleep Scale (MOS) [Time frame: at weeks 4, 8, and 12 after experimental drug medication]
  • Adverse events [Time frame: Through study completion, an average of 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing

Identifiers

NCT: NCT07378046 · KY2025-369-02-6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗