Fibromyalgia is a central sensitization syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbance, and cognitive difficulty ("fibro fog"), affecting approximately 2–4% of the global population, predominantly women. The pathophysiology involves abnormal central pain processing — amplified pain signals due to dysregulation of neurotransmitter systems including serotonin, norepinephrine, and substance P — rather than peripheral inflammation or tissue damage, distinguishing fibromyalgia from inflammatory arthritis or neuropathy.
Active trials investigate low-dose naltrexone for neuroinflammation, cannabidiol and endocannabinoid-targeting approaches, transcranial direct current stimulation (tDCS), mindfulness-based cognitive therapy combined with pharmacotherapy, milnacipran analogs with improved tolerability, and patient-reported digital biomarkers using actigraphy and ecological momentary assessment. Sleep intervention trials addressing the relationship between restorative sleep and pain amplification are an emerging area.
Fibromyalgia trials use the ACR 2010/2016 diagnostic criteria and require a minimum pain intensity score on a 0–10 NRS; previous failure of at least one FDA-approved therapy (pregabalin, duloxetine, or milnacipran) is required for most third-line trials.
Frequently Asked Questions — fibromyalgia syndrome Clinical Trials
How many clinical trials are currently recruiting for fibromyalgia syndrome?
ClinicalMetric currently tracks 2 actively recruiting clinical trials for fibromyalgia syndrome, sourced in real time from ClinicalTrials.gov. The total number of registered studies—including those not yet enrolling or in active follow-up—is 2. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for fibromyalgia syndrome?
fibromyalgia syndrome research spans Phase 2 (1 trial). Phase 1 studies evaluate safety and dosing in small groups, Phase 2 studies assess preliminary efficacy in 100–300 participants, and Phase 3 trials compare the new treatment against the standard of care in 300–3,000+ patients. Phase 4 post-approval studies monitor long-term outcomes in real-world populations.
How do I find out if I qualify for a fibromyalgia syndrome clinical trial?
Eligibility criteria for fibromyalgia syndrome trials vary by study and typically specify age range, disease stage or severity, prior treatment history, and specific diagnostic or laboratory parameters. Each listing on ClinicalMetric links to the full protocol on ClinicalTrials.gov, where inclusion and exclusion criteria are documented. Contact the sponsoring site's research coordinator directly to confirm your eligibility—your treating physician or specialist can also help identify the most appropriate trial based on your medical history and current treatment status.
Top Sponsors
University of Utah 1 trial
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 1 trial
Recruiting Clinical Trials
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional.
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Last Reviewed: April 2026 ·
Data Methodology