Venlafaxine to prevent postherpetic neuralgia after shingles
The Analgesic Efficacy and Safety of Oral Medications (Venlafaxine) for Prevention of Postherpetic Neuralgia in Acute Herpes Zoster
This study will test whether giving venlafaxine to adults with recent shingles reduces the chance of developing postherpetic neuralgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 832 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07361796 on ClinicalTrials.gov |
What this trial studies
This interventional trial will compare venlafaxine plus conventional therapy versus conventional therapy alone in adults with recent-onset shingles and moderate to severe pain (NRS ≥4). Eligible participants must have rash onset within 30 days and adequate liver and kidney function, while patients with head/neck/ocular involvement, major depressive disorder requiring antidepressants, known venlafaxine hypersensitivity, or certain immune or cancer conditions are excluded. Participants will receive assigned treatment and be followed for pain outcomes and safety measures to determine whether venlafaxine prevents the transition to chronic postherpetic neuralgia. The study is conducted at Beijing Tiantan Hospital with collaborating centers listed by the sponsor.
Who should consider this trial
Good fit: Adults over 18 with shingles rash onset within 30 days, average pain of at least 4/10 on the NRS, and acceptable liver and kidney function who can give informed consent and attend study visits.
Not a fit: People with head/neck/ocular or generalized shingles, pregnancy or lactation, known venlafaxine allergy, a history of major depressive disorder requiring antidepressants, significant immunosuppression or organ transplantation, or inadequate organ function are excluded or unlikely to benefit.
Why it matters
Potential benefit: If successful, venlafaxine could lower the risk of developing long-lasting postherpetic neuralgia and shorten the duration or severity of acute shingles pain.
How similar studies have performed: SNRIs like venlafaxine have shown benefit for established neuropathic pain, but using venlafaxine specifically to prevent postherpetic neuralgia is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Ages more than 18 years; * 2\. Patients with onset of HZ rash less than 30 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\. HZ with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system involvement or generalized HZ; * 2.Known hypersensitivity to venlafaxine; * 3.History of major depressive disorder requiring antidepressant therapy; * 4.History of systemic immune diseases, organ transplantation, or cancers; * 5.Pregnancy or lactation; * 6.Presence of 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
- Email: 13611326978@163.com
- Phone: 13611326978
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.