Living with pain others can't see?
See if the FORWARD Fibromyalgia study is right for you.
Who Can Participate?
The FORWARD Fibromyalgia study is looking for people who*:
- Are at least 18 years of age
- Have fibromyalgia or experience the symptoms of fibromyalgia (muscle, joint, and bone pain, trouble sleeping, etc.)
- Do not have any other conditions that cause pain besides fibromyalgia
- Are interested in participating in the clinical study
How Do I Participate?
Step 2
If you meet certain conditions and want to learn more, your information will be sent to a research site near you.
Step 3
Research site staff will contact you to talk more about the study and get more information on your health history. You may be invited to the research site to complete a screening visit.
Step 4
At the research site, the study doctor will talk to you about your participation in the study. After you have asked all of your questions, you will be asked to sign a consent form.
Click the button below to fill out a quick form to see if you may be eligible for the FORWARD study.
By filling out this form, you are under no obligation to participate in the study. Your information will be forwarded to the study site closest to you where a member of the staff will reach out via phone, email, or text to collect more information.
About the Study
If you meet the above criteria, the FORWARD Fibromyalgia research study may be of interest to you. This study is looking at how an investigational medication AXS-14, also known as esreboxetine, may help with fibromyalgia pain and other symptoms in adults.
AXS-14 is an investigational medication for fibromyalgia. This means it has not yet been approved by the FDA for use in fibromyalgia. Eligible participants will receive study-related care and evaluations at no cost. Each participant’s fibromyalgia and overall health will be monitored by a team of physicians and study staff. Compensation for your time and travel may be available.
What to Expect
If you are eligible and choose to participate in the FORWARD study, you may be in the study for up to 30 weeks. There are up to 12 in-person visits at the study site and up to 2 remote visits by phone*. As a participant in the study, it is important to understand how many visits you will be attending when you make the decision to participate.
*Some participants may have the opportunity to start a 52-week open-label extension study, where all participants take AXS-14.
Screening Period
(Up to 4 weeks)
This is the time when the study doctor and staff determine if you are eligible for the study. You will come in for your first visit and will answer some questions and do some medical tests to see if you may be a good fit for the study. You will be asked to complete a daily electronic diary to track your pain symptoms
Open-Label Treatment Period
(12 weeks)
If you are eligible to participate, you will then enter the study treatment period which lasts for 12 weeks and involves up to 5 in-person visits.
This part of the study is open label, meaning that all study participants will take AXS-14. You will also continue your electronic diary during this period.
Double-Blind Randomized Withdrawal Period
(12 weeks)
Based on symptoms and the results of study tests, some participants may start the double-blind randomized withdrawal period. This part of the study involves up to 5 in-person visits and 2 remote visits.
Participants will be randomly assigned to take AXS-14 or the placebo during this period. The study doctor, study staff, study Sponsor, and participants will not know who is taking AXS-14 or placebo*.
*A placebo is a pill that looks like the study drug but does not contain any active ingredients
At the in-clinic visits, you can expect some of the following assessments:
Vital Signs
ECG
Medical History
Blood and Urine Samples
Health Questionnaires
Daily Pain Electronic Diary
Why Participate?
If you’re living with fibromyalgia, the FORWARD study may be right for you. If you are eligible to participate:
- You may receive the investigational medication
- You may receive study-related care and study evaluations at no cost
- You may also receive compensation for your time and travel
- You may have the opportunity to help advance an investigational medication for people with fibromyalgia*
What is Fibromyalgia?
Fibromyalgia is a chronic condition that causes muscle, bone, and joint pain across the body. It often impacts daily life and can be difficult to manage. In fibromyalgia, the central nervous system is more sensitive. This can cause normally not painful sensations to feel painful. Although pain is a main symptom of fibromyalgia, it is not the only symptom. The condition can cause fatigue, trouble sleeping, brain fog, and more.1
In the United States, fibromyalgia impacts millions of adults. The condition can occur in both men and women of all backgrounds. However, approximately 80 to 90% of those with the condition are women.2 People who have fibromyalgia often can feel misunderstood. Worrying about symptoms getting worse and not knowing what to expect can have a big impact on life.
If you believe you may be living with fibromyalgia, fill out the form above to speak with a fibromyalgia expert.
References
[1] Sarzi-Puttini, P., Giorgi, V., Marotto, D. et al. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol 16, 645–660 (2020). https://doi.org/10.1038/s41584-020-00506-w
[2] Ruschak, I., Montesó-Curto, P., Rosselló, L., Aguilar Martín, C., Sánchez-Montesó, L., & Toussaint, L. (2023). Fibromyalgia Syndrome Pain in Men and Women: A Scoping Review. Healthcare (Basel, Switzerland), 11(2), 223. https://doi.org/10.3390/healthcare11020223
FAQs
A clinical research study, also called a clinical trial, tests the safety and efficacy of an investigational medicine in human volunteers. Every medication on the market has gone through this process, meaning volunteers are an important part of advancing medicine for present and future generations.
AXS-14 contains a medication called esreboxetine. It is a highly selective and potent norepinephrine reuptakeinhibitor. AXS-14 has met the primary endpoints and demonstrated positive results in a Phase 3 and in a Phase 2 trial for the treatment of fibromyalgia. However, it’s an investigational medication for fibromyalgia, and has not been approved by the FDA.
Clinical studies can be sponsored, or funded, by a pharmaceutical or biotechnology company, academic medical center, or health care provider. Every clinical study is held at one or more sites that are led by a principal investigator (study doctor) and their research team. The FORWARD study is sponsored by Axsome Therapeutics.
A placebo looks like the investigational medication but does not contain any active ingredients (medicine). Taking placebo is as if the participant was not taking anything at all. In this study, placebo is used to compare the effects of the investigational medication. Neither the participant nor the study doctor will know if they are taking the investigational medication or placebo. In case of a medical emergency, the study doctor will be able to find out which group the participant belongs to.
In order to participate in a study, you will need to first take some tests and discuss your medical history with the study doctor to ensure that you meet all criteria for participation. You will also review and sign an informed consent form which lays out what will happen in the study, your rights and responsibilities as a participant, and the risks and potential benefits of the study. Once you are eligible and enrolled, you will visit the study site regularly to monitor your progress and overall health. Yes, study participation is absolutely voluntary. You have the right to end participation at any time for any reason. In case you decide to drop out of the study, please speak with the study doctor first.
For more information about the study, visit ClinicalTrials.gov/NCT07398417. For more information about Axsome Therapeutics, the study sponsor, visit axsome.com.