Research Study in Cincinnati Looks Into A New Potential Treatment for Fibromyalgia
Research Center: University of Cincinnati
Location: 260 Stetson Street Suite 3200 Cincinnati, Ohio 45219
Lead Doctor: Lesley Mussio Arnold, MD
IRB Committee: This study has been reviewed and approved by the Copernicus Group Independent Review Board (CGIRB) and the Western Institutional Review Board® (WIRB®)
About 2 to 4 percent of the U.S. population has fibromyalgia. Fibromyalgia is a condition described as widespread pain throughout the body including the muscles, joints, ligaments, limbs, neck, and back. It is usually accompanied by fatigue, sleep, memory, and mood issues. Those who have fibromyalgia can also suffer from tension headaches, temporomandibular joint (TMJ) disorders, irritable bowel syndrome, anxiety, and depression.
This study seeks to investigate the effectiveness of a potential new treatment for fibromyalgia. Researchers also want to know which dosage of this investigational medication is helpful in managing fibromyalgia symptoms. This new potential treatment is FDA-approved for treating migraine headaches.
Interested participants must be 18 to 75 years old who have fibromyalgia. They must attend 8 study visits at the research site for over approximately 35 weeks. Participants must also comply with all the necessary study requirements stated in a section below.
- You may experience improvements in your fibromyalgia symptoms (including potential pain relief).
- You will be given rescue medication for sudden fibromyalgia symptoms (like pain)at no cost.
- You will be compensated up to $600 ($75 per site visit) for participating in this study.
- You will be contributing valuable information that may help researchers understand fibromyalgia and its potential treatment.
- You may be helping others who also suffer from fibromyalgia in the future.
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
- Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- Men and women aged 18-75 years old who suffer from fibromyalgia.
- Able to attend 8 study visits at the research site over approximately 35 weeks.
- Must be willing to comply with all the following study requirements:
- Complete questionnaires and e-diary entries
- Willing to have biological samples (such as blood and urine) taken
- Undergo physical examinations and electrocardiograms (ECG)
- Receive the new potential treatment via injections
Due to the current situation with COVID-19 pandemic, the study team would like to point out the following:
- The research site does not treat COVID-19 patients and/or suspected COVID-19 patients.
- The research site’s waiting area is spacious enough that participants will not be within close proximity to each other.
- Hand sanitizers are available at the research site.
- The research staff adheres to strict hygienic practices as well as other safety measures to prevent the spread of COVID-19.
- Any staff suspected to have COVID-19, or has come into contact with someone who has COVID-19, will automatically undergo a voluntary quarantine for 14 days.
- Interested participants will not be left waiting for a long period of time and will be quickly attended to.
- Parking is available at the research site.
- The study team encourages the use of personal vehicles, taxi or rideshare services rather than public transit. All travel expenses will be reimbursed.
- The research site/institution is taking all precautionary measures to ensure the safety of the study participants.