Baclofen for relieving pain from herpes zoster
Official title: The Analgesic Efficacy and Safety of Oral Medications (Baclofen) in Patients With Herpes Zoster
Run by Beijing Tiantan Hospital · NCT07378046 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT07378046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Baclofen has shown benefit for some acute musculoskeletal pain, but its use specifically for herpes zoster pain is relatively novel and not well established.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China Recruiting
Study contacts
- Study coordinator: Fang Luo
- Email: 13611326978@163.com
- Phone: 13611326978
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.