Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. Researchers believe that fibromyalgia amplifies painful sensations by affecting the way your brain and spinal cord process painful and non painful signals.
Currently there are an estimated 6 to 12 million people who suffer from fibromyalgia. Fibromyalgia is classified as a chronic pain disorder, presenting with symptoms such as pain across the body that is difficult to treat or manage, insomnia and fatigue. This often makes it difficult to complete daily activities, such as walking short distances and using the stairs. Typically affecting women in higher numbers than men, there is also increased likelihood of developing fibromyalgia if an immediate family member has been diagnosed!
Finding appropriate treatments for fibromyalgia can be difficult, as many who have the condition often need a trial-and-error approach. This is not a one size fits all condition, requiring attentive doctors and patients alike to work together to find the right therapeutic combination.
Clinical Study: This research study is evaluating an investigational new drug to determine if it might reduce symptoms associated with fibromyalgia. Patients who enroll in this study will be asked to participate for up to 16 weeks. Study participants will be asked to take the study drug once a day. During study, participants will be randomly placed into different study groups. Two groups will receive the study drug being tested, and one group will receive a placebo. A placebo looks like the study drug, but it won’t have any effect on the person who gets it. Participants will also be asked to complete handheld study diary entries at least twice daily to track their progress throughout the study. Each person will be provided an electronic handheld device to complete this task.
- Be 18 to 75 years old
- Have a diagnosis of fibromyalgia for more than one year
- Discontinue pain medications for fibromyalgia and agree to use only acetaminophen, as needed, for breakthrough pain related to fibromyalgia
Other eligibility criteria apply. Study participants receive study-related medical exams and study drug at no cost. Compensation for time and travel is available.
Importance of Clinical Trials:
Clinical research studies, also known as clinical trials, are designed to answer specific questions about study drugs and are needed to help find new and possibly better future treatments for diseases. A study drug goes through several phases of clinical research to evaluate its safety and effectiveness. Depending on the results of the research, the study drug could later be available to the public. An external review board made up of doctors, ethicists, members of the general public, and administrators help to ensure that a clinical trial does not present an unreasonable risk to individuals who are participating. Your own doctor is responsible for your well-being and you may speak with him or her to discuss clinical trial participation before you decide to join. Whenever you agree to enter a clinical trial, you are given the name and telephone number of a contact in your study doctor’s office who will answer any questions you may have.