Tulodesvenlafaxine to relieve herpes zoster (shingles) pain

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

This trial tests whether adding tulodesvenlafaxine to standard care can reduce moderate-to-severe shingles pain in adults.

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: NCT07370389 on ClinicalTrials.gov

What this trial studies

Adults with recent herpes zoster (rash onset under 90 days) and moderate-to-severe pain (NRS ≥4) will receive standard antiviral/analgesic therapy either alone or combined with tulodesvenlafaxine, with liver and kidney function requirements for enrollment. The study compares pain scores and safety outcomes between the two groups over the treatment period. Patients with disseminated or ocular HZ, prior tulodesvenlafaxine use, or known hypersensitivity to the drug are excluded. The approach tests whether increasing central serotonin and norepinephrine availability can provide additional analgesia beyond conventional therapy.

Who should consider this trial

Good fit: Adults aged over 18 with a shingles rash that began less than 90 days ago, average pain of at least 4 on a 0–10 NRS, and adequate liver and kidney function who can consent and comply with visits.

Not a fit: Patients with disseminated or ocular herpes zoster, significant liver or renal impairment, prior tulodesvenlafaxine exposure, or those beyond the 90-day window may not benefit from this approach.

Why it matters

Potential benefit: If successful, adding tulodesvenlafaxine could meaningfully reduce acute shingles pain and potentially lower the risk of longer-term postherpetic neuralgia while maintaining acceptable safety.

How similar studies have performed: Other antidepressants and SNRIs (for example duloxetine and venlafaxine) have shown analgesic effects in neuropathic pain and postherpetic neuralgia, but evidence specifically for acute herpes zoster pain is limited.

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 tulodesvenlafaxine;
* 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 tulodesvenlafaxine;
* 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