ATHENA
Research type
Research Study
Full title
AmiTriptyline for the prevention of post-HErpetic NeuralgiA (ATHENA): multi-centre, individually randomised, pragmatic, placebo-controlled superiority trial with internal pilot, health economic analysis, study within a trial and nested qualitative study
IRAS ID
1003967
Contact name
Matthew Ridd
Contact email
Sponsor organisation
University of Bristol
Eudract number
2021-001101-78
Research summary
Shingles is caused by the chickenpox virus, herpes zoster. It “sleeps” in the nerve cells for decades. When it “wakes up”, it can make people feel generally unwell, cause tingling or pain in one part of the body, followed a few days later by a rash. The rash can take up to 4 weeks to heal. Antiviral medicine helps reduce initial pain and rash severity.
Some people can have “nerve pain” months after the shingles rash has gone. Called post-herpetic neuralgia, we don’t have any treatments to prevent this. A previous, small study suggested that taking a low dose of amitriptyline early on may help prevent post-herpetic neuralgia. We want to do a clinical trial to find out if using amitriptyline when the rash first appears really prevents pain of post-herpetic neuralgia later on.
If starting amitriptyline early on does help, it is a cheap medicine that would prevent prolonged, difficult-to-treat pain for thousands of people. However, amitriptyline commonly causes side-effects such as dizziness, dry mouth and constipation. It can also cause problems when used together with some other tablets. This study is needed so we can be sure that any benefits outweigh any harms.
We will recruit 846 people aged >50 years who have been diagnosed by their GP with shingles. First, we will explain the study and receive consent. Next, we will randomise everyone to take 1-3 tablets nightly (as tolerated) for 10 weeks. Half will be given amitriptyline and the other half will get placebo (or “dummy”) tablets. After that, we will follow participants up with questionnaires at 30, 60, 90, 120, 180 and 360 days. Our main outcome will be whether they still have pain related to shingles at 90 days. All other care will be the same – this includes GPs prescribing antivirals and painkillers if needed.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0130
Date of REC Opinion
19 Oct 2021
REC opinion
Favourable Opinion