Local doctors need your help with a research study testing an investigational pain medication for fibromyalgia.

Why is this study being conducted?

Although there are treatments available to manage fibromyalgia pain, many patients struggle to control their pain or are negatively affected by side effects. So it’s vital we continue to investigate potential new treatments like DS-5565.

DS-5565 is an oral pain medication under development for the treatment of fibromyalgia-associated pain. This study will allow us to learn more about the safety and effectiveness of DS-5565 in people who:

  • Are at least 18 years of age
  • Have been experiencing the same level of pain for at least 3 months
  • Have been diagnosed with fibromyalgia or think they may have the condition

Participants must meet additional criteria and a doctor will determine if you are eligible to take part in the study. Fibromyalgia symptoms you may be experiencing will be assessed at your first two visits to the research study site.

What will happen during this study?

Study participation will last about 21 weeks. During the 13-week treatment stage, you’ll take one of the following:

  • The investigational drug
  • An approved neuropathic pain treatment
  • A placebo (a substance containing no medication)

This treatment is assigned randomly (by chance) and neither you nor your doctor will be able to choose your group or know which one you are in.

How will my health be monitored?

So we can monitor your health closely, you’ll be asked to record daily information about any pain or sleep trouble you experience. You’ll also attend regular clinic visits (once every 1-2 weeks) for various tests and assessments. These may include questions about health, physical examinations and blood tests.

You should continue to see your primary healthcare provider during the study. The study team does not replace your primary healthcare provider. Let your provider know if you are participating in the research study.

Some final things to note

All study-related visits, tests and drugs will be provided to participants at no cost. Compensation for study-related time and travel may also be available.

Once this study ends, eligible patients will be invited to participate in an extension study. During that phase of the study, all patients will take the investigational drug, DS-5565.

Click here to find a research site and see if this study is right for you.