Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Home › Conditions › Fibromyalgia

Fibromyalgia

11 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Fibromyalgia

113 trials tracked for Fibromyalgia: 42 in phase 3 or 4 and 7 with published results. The most-cited published study has 49 citations.

113Trials tracked
42Phase 3 & 4
0Recruiting
7With published results
Phase distribution
Phase 4 11 Phase 3 31 Phase 2 24 Phase 1 1 Other / NA 46
  1. Phase 3 A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia Completed · 49 cited
  2. Phase 4 Pregabalin In Adolescent Patients With Fibromyalgia Completed · 46 cited
  3. Phase 3 A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome Completed · 45 cited
  4. Phase 4 Drug and Talk Therapy for Fibromyalgia Completed · 37 cited
  5. Phase 3 Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients Completed · 26 cited
  6. Phase 3 A Study For Pregabalin In Patients With Fibromyalgia Completed · 22 cited
Show 44 more trials
  1. Phase 3 A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia Completed · 15 cited
  2. Phase 4 Effect of Milnacipran on Pain in Fibromyalgia Completed
  3. Phase 4 Eszopiclone in the Treatment of Insomnia and Fibromyalgia Completed
  4. Phase 4 A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia Completed
  5. Phase 4 Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia Completed
  6. Phase 4 A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia Completed
  7. Phase 4 Adolescent Fibromyalgia Study Completed
  8. Phase 4 An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain Completed
  9. Phase 4 Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia Completed
  10. Phase 4 The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia Completed
  11. Phase 3 Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study Completed
  12. Phase 3 Combined Behavioral and Analgesic Trial for Fibromyalgia Completed
  13. Phase 3 Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease Completed
  14. Phase 3 A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia Completed
  15. Phase 3 The Innate Central Nervous System Immune Response to an Experimental Immune Challenge in People With Fibromyalgia Completed
  16. Phase 3 A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia Completed
  17. Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia Completed
  18. Phase 3 Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome Completed
  19. Phase 3 Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia Completed
  20. Phase 3 Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia Completed
  21. Phase 3 A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia. Completed
  22. Phase 3 The Effect of Milnacipran in Patients With Fibromyalgia Completed
  23. Phase 3 Study of Milnacipran for the Treatment of Fibromyalgia Completed
  24. Phase 3 A Study Of Milnacipran In Patients With Fibromyalgia: Effects On 24 Hour Ambulatory Blood Pressure Monitoring Completed
  25. Phase 3 Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia Completed
  26. Phase 3 A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression Completed
  27. Phase 3 This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia Completed
  28. Phase 3 Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia Completed
  29. Phase 3 Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia. Completed
  30. Phase 3 A Study of Duloxetine in Fibromyalgia Completed
  31. Phase 3 A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia Completed
  32. Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia. Completed
  33. Phase 3 A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia Completed
  34. Phase 3 Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia : A 13-week Randomized, Placebo Controlled Cross Over Trial Completed
  35. Phase 3 An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057) Completed
  36. Phase 3 Coping Skills Training for Adolescents With Fibromyalgia Completed
  37. Phase 2 Neurotropin Treatment of Fibromyalgia Completed
  38. Phase 2 A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome Completed
  39. Phase 2 Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia Completed
  40. Phase 2 Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia Completed
  41. Phase 2 The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome Completed
  42. Phase 2 Heart Rate Variability in Response to Metformin Challenge Completed
  43. Phase 2 Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia Completed
  44. Phase 2 Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia Completed

Showing the 50 most-cited and recently-updated of 113 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Fibromyalgia: what the trials found

Pregabalin has demonstrated significant improvements in pain scores over multi-week periods 17 and showed a statistically significant reduction in mean pain scores at the 14-week mark compared to placebo 18. Additionally, pregabalin was associated with a significantly longer time to loss of therapeutic response (LTR) 17.

Duloxetine hydrochloride is associated with significant improvements in patient global impressions of improvement (PGI-I), reductions in Brief Pain Inventory (BPI) scores, and improvements in multidimensional fatigue inventory (MFI) scores at 12 weeks 14. In adolescent populations, duloxetine showed a trend toward reducing pain severity and interference 15.

TNX-102 SL has shown statistically significant reductions in Numerical Rating Scale (NRS) average daily pain scores [16, 19] and improvements in Fibromyalgia Impact Questionnaire - Revised (FIQ-R) symptoms and function domains [19, 20, 22]. One study also reported a higher number of patients achieving 'much improved' or 'very much improved' ratings on the PGIC scale with TNX-102 SL 22.

Milnacipram treatment was associated with significantly lower concentrations of Substance P in cerebrospinal fluid following pain stimuli and a significant reduction in sensory thresholds for temperature pain 7. Milnacipram also showed statistically significant improvements in sleep efficiency 8.

Recent results — preliminary, needs further review

  • - A 5% lidocaine/5 mg/ml 0.02% estradiol compound cream was evaluated; while it showed a statistically significant improvement in physical health scores (SF12v2), it did not produce a statistically significant change in pain scores via the Tampon Test or the SF-MPQ 1.
  • - Alpha-stim and Phone-Based Walk With Ease are currently under investigation but lack reported outcome data in the provided trials [2, 3].

For the clinician treating this condition

  • Pregabalin is established as an effective intervention for reducing pain scores and extending the duration of therapeutic response in fibromyalgia patients.
  • Duloxetine provides evidence-based improvements in both pain intensity and associated fatigue symptoms.
  • TNX-102 SL demonstrates consistent efficacy in reducing NRS pain scores and improving functional outcomes measured by FIQ-R scales.
  • Milnacipram shows potential for managing sensory thresholds and improving sleep efficiency.

AI synthesis of 8 cited trials, updated Jun 24, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Retrospective reports of pain intensity are significantly higher than daily diary reports in JFM
Psychiatry RCT
Retrospective reports of pain intensity are significantly higher than daily diary reports in JFM Teenagers with fibromyalgia report more pain when looking back
This randomized controlled trial of 317 adolescents with juvenile fibromyalgia (JFM) found that retrospective reports of pain intensity were…
Teenagers with juvenile fibromyalgia often report higher pain levels when looking back at their week rather than recording it daily.
Oct 2, 2026
Exercise reduces inflammatory markers in 45.6% of meta-analytic associations, but evidence quality is low
Pulmonology & Critical Care Sys. Review
Exercise reduces inflammatory markers in 45.6% of meta-analytic associations, but evidence quality is low Exercise Shows Link to Lower Inflammation in Chronic Diseases
This umbrella review of 61 meta-analyses (318 associations) found that exercise significantly reduced circulating inflammatory markers in 45…
New research shows that regular exercise may lower key markers of inflammation for people living with chronic conditions like heart disease …
Frontiers Aug 26, 2026
Endometriosis genetic risk score tied to pain, cardiometabolic conditions in both sexes
Genetics & Precision Medicine Meta-analysis
Endometriosis genetic risk score tied to pain, cardiometabolic conditions in both sexes Genetic Risk for Endometriosis Linked to Chronic Pain Conditions
This meta-analysis links an endometriosis polygenic risk score (PRS) to 20 of 29 comorbidities in women and to pain and cardiometabolic cond…
A large genetic study reveals that the same genetic markers linked to endometriosis are also associated with fibromyalgia, migraine, and bac…
medRxiv Jun 24, 2026
Fibromyalgia as an oncology comorbidity increases symptom burden and impairs treatment adherence
Anesthesiology & Pain Medicine Meta-analysis
Fibromyalgia as an oncology comorbidity increases symptom burden and impairs treatment adherence Fibromyalgia makes managing cancer pain more difficult for patients
This systematic review of 11 studies examines fibromyalgia as a comorbidity in cancer patients. The findings indicate that fibromyalgia cont…
Patients with both fibromyalgia and cancer face higher symptom burdens and may stop life-saving treatments sooner due to intense, amplified …
Frontiers Jun 14, 2026
Narrative review discusses link between diamine oxidase deficiency and fibromyalgia pathophysiology
Anesthesiology & Pain Medicine RCT
Narrative review discusses link between diamine oxidase deficiency and fibromyalgia pathophysiology DAO supplementation may reduce fibromyalgia pain and impact
This narrative review examines the relationship between histamine intolerance, diamine oxidase (DAO) deficiency, and fibromyalgia.
New evidence suggests that addressing diamine oxidase deficiency could help reduce pain and improve daily life for some people with fibromya…
Frontiers Apr 30, 2026
Paraprobiotic supplementation associated with improved bodily pain in women with fibromyalgia over 2 months
Rheumatology Cohort
Paraprobiotic supplementation associated with improved bodily pain in women with fibromyalgia over 2 months Fibromyalgia Pain May Ease with New Type of Probiotic
This retrospective observational study of 86 women with fibromyalgia found that paraprobiotic supplementation was associated with a signific…
She wakes up every morning bracing for the ache.
Frontiers Apr 24, 2026
Case series suggests pain relief and quality of life improvement with multimodal therapy in fibromyalgia
Diabetes & Endocrinology Cohort
Case series suggests pain relief and quality of life improvement with multimodal therapy in fibromyalgia Small case series suggests combined therapies may help three patients with fibromyalgia
This case series evaluated 3 patients with refractory fibromyalgia using low frequency Pulsed Electromagnetic Field therapy, medical ozone i…
Three patients with tough fibromyalgia cases found lasting pain relief and better quality of life after a 30-day mix of PEMF therapy, ozone,…
Frontiers Apr 16, 2026
Mindfulness Based Stress Reduction improves quality of life and pain catastrophising in fibromyalgia patients
Psychiatry Meta-analysis
Mindfulness Based Stress Reduction improves quality of life and pain catastrophising in fibromyalgia patients Mindfulness training helps quality of life and pain thinking for fibromyalgia patients
This systematic review and meta-analysis evaluated Mindfulness Based Stress Reduction (MBSR) in 1153 people with fibromyalgia.
Mindfulness training improves quality of life and pain thinking for fibromyalgia patients, offering relief from widespread pain and exhausti…
Apr 6, 2026
CBT and exercise therapies reduce pain disability in juvenile fibromyalgia without clear superiority
Pediatrics RCT
CBT and exercise therapies reduce pain disability in juvenile fibromyalgia without clear superiority Three therapies similarly reduce disability in teens with juvenile fibromyalgia
A randomized controlled trial of 317 adolescents with juvenile fibromyalgia compared CBT alone, graded aerobic exercise alone, and combined …
Three teen pain therapies worked equally well to reduce disability in juvenile fibromyalgia, showing no single approach was better than the …
Apr 4, 2026
Health education programs added to fibromyalgia care reduce pain and improve quality of life in meta-analysis
Anesthesiology & Pain Medicine Meta-analysis
Health education programs added to fibromyalgia care reduce pain and improve quality of life in meta-analysis Can learning about fibromyalgia help ease the pain? A review suggests it might
A systematic review and meta-analysis of 7 randomized controlled trials in fibromyalgia patients found that adding health education programs…
Learning about fibromyalgia significantly reduces pain and improves daily life when added to standard medical care, according to a new revie…
Apr 3, 2026
Network meta-analysis ranks exercise modalities for fibromyalgia impact in women
Physical Medicine & Rehab Meta-analysis
Network meta-analysis ranks exercise modalities for fibromyalgia impact in women Study compares exercise types for women with fibromyalgia, finds Pilates and aquatic exercise promising
A network meta-analysis of 59 RCTs (n=3256) in women with fibromyalgia compared 14 exercise modalities.
For women with fibromyalgia, Pilates, swimming, and resistance training offer the best short-term relief, while dance and mixed programs wor…
Apr 2, 2026

Questions about Fibromyalgia

Can low frequency electromagnetic field therapy help patients with refractory fibromyalgia?

Early research suggests low frequency electromagnetic field therapy may reduce pain in some fibromyalgia patients, but evidence is limited and more studies are needed.

Full answer →
Does combining CBT and exercise work better for juvenile fibromyalgia pain?

A 2024 trial found that combining CBT with specialized exercise did not outperform CBT or exercise alone for juvenile fibromyalgia pain disability, though all treatments helped.

Full answer →
Does mindfulness training improve quality of life for people with fibromyalgia?

Yes, mindfulness training, particularly Mindfulness Based Stress Reduction (MBSR), improves quality of life and reduces pain catastrophising in people with fibromyalgia, with benefits lasting up to 3 years.

Full answer →