Baclofen for relieving pain from herpes zoster

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

We will try baclofen alongside standard care to reduce moderate to severe shingles pain in adults who developed rash within the past 90 days.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07378046 on ClinicalTrials.gov

What this trial studies

Adults with herpes zoster who have had a rash for less than 90 days and report average pain of at least 4/10 are enrolled. Participants receive either baclofen in addition to conventional therapy or conventional therapy alone, with monitoring of liver and kidney function. The trial tracks pain intensity and adverse events to determine whether baclofen provides additional analgesia and is safe in this setting. Key exclusions include prior baclofen use, disseminated or ocular HZ, and known hypersensitivity to baclofen.

Who should consider this trial

Good fit: Adults aged over 18 with herpes zoster rash onset under 90 days, average pain ≥4/10, acceptable liver and kidney tests, and capacity to consent are ideal candidates.

Not a fit: Patients with prior baclofen exposure, disseminated or ocular herpes zoster, significant hepatic or renal impairment, or baclofen allergy may not benefit or be eligible.

Why it matters

Potential benefit: If successful, baclofen could provide better or faster pain relief for shingles and might reduce the risk of long-term postherpetic neuralgia.

How similar studies have performed: Baclofen has shown benefit for some acute musculoskeletal pain, but its use specifically for herpes zoster pain is relatively novel and not well established.

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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Herpes Zoster; Pain