What is a clinical trial?
A clinical research study is a research project done with human volunteers to learn more about new investigational drugs and treatments. Some volunteers are interested in access to investigational drugs or treatments. While others volunteer to help advance science. Whatever your reason is for participating, we’ll monitor your health and protect your privacy.
What is an investigational study drug?
“Investigational” means it’s not yet approved by the FDA or available for use by the public.
Why should I participate in a clinical trial?
Participating in a clinical trial may allow you to have access to investigational new drugs or treatments not currently available for use by the public for your condition. Clinical trials are how we advance in development in new treatments. Any medications that you are currently taking have undergone clinical trials to obtain FDA approval.
The Valnivudine™ clinical trial is currently enrolling at sites around the United States to test an investigational medication, known as Valnivudine™, for shingles and debilitating post-herpetic neuralgia (PHN) pain.
Are health insurance and referrals required to participate in the Valnivudine™ Clinical Trial?
Health insurance and referrals are not required to participate. All study medication as well as study-related procedures will be provided at no cost.
What is the shingles vaccine?
The shingles vaccine is specifically designed to protect people against shingles and will not protect people against other forms of herpes, such as genital herpes. The shingles vaccine is not recommended to treat active shingles or post-herpetic neuralgia (pain after the rash is gone) once it develops.
Shingles vaccination is costly (usually $200-$300), and may not be covered by insurance. Because the shingles vaccine has not been available for long, it is still unclear how long protection lasts, so a booster shot might be necessary in the future at an additional cost.
What is the investigational study drug for the Valnivudine™ Clinical Trial?
Valnivudine™ is the name of the investigational study drug to be used in the trial. It is a fast-acting, low dose, once-daily oral antiviral agent being developed for herpes zoster, or shingles and has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain, known as PHN.
What are the early signs and symptoms of shingles?
The first sign of shingles is often pain, burning or tingling on one side of the body. Next, a painful rash with blisters will develop in the same area. Learn more about shingles >>
What is the most common complication of shingles?
Post-herpetic neuralgia (PHN) is the most common complication of shingles. PHN is pain that continues for a long time after a shingles rash has disappeared. Learn more about shingles >>
What is the importance of the 5 day window?
For treatments to be most effective, doctors recommend that treatment start within 5 days of the rash appearing. People who have or think they might have shingles should seek medical attention as soon as possible.
You must also be able to receive the first dose of study medication within 5 days of a possible shingles rash appearing
How do I determine if I qualify for the clinical trial?
Please take our brief questionnaire to determine if you pre-qualify for the clinical trial. Feel free to also contact a testing center near you for further information.
Where do I find a clinical trial site near me?
Please visit the testing center page to identify the closest clinical trial site.