80 completed, 8 terminated, 5 unknown, 2 withdrawn. 97 Phase 3, 16 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 97 | Completed 80, Terminated 8, Unknown 5, Withdrawn 2, Enrolling by invitation 1, Recruiting 1 |
| Phase 2 | 16 | Completed 13, Unknown 2, Terminated 1 |
Follow Fibromyalgia: new trials by email Literature Review of Fibromyalgia trials Research Report on Fibromyalgia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia AXS-14 (esreboxetine) - Fibromyalgia | Phase 3 | Enrolling by invitation | Axsome Therapeutics, Inc. | 300 | 2026-04-29 | 2026-10-13 |
| Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design AXS-14 (Esreboxetine), Placebo - Fibromyalgia | Phase 3 | Recruiting | Axsome Therapeutics, Inc. | 620 | 2026-01-14 | 2026-09-04 |
| Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia Lidocaine and Dexamethasone, Normal Saline - Fibromyalgia | Phase 2 / Phase 3 | Completed | Sanliurfa Education and Research Hospital | 68 | 2025-06-01 | 2026-01-16 |
| CBD (Cannabidiol)/THC (Tetrahydrocannabinol) Solution as a Pharmacological Strategy for Patients With Fibromyalgia (FibroCann) cannabidiol and tetrahydrocannabinol, Placebo - Fibromyalgia | Phase 2 / Phase 3 | Unknown | FG Brasil LTDA | 40 | 2022-04-15 | 2022-04-11 |
| A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia TNX-102 SL Tablet, 5.6 mg, Placebo SL Tablet - Fibromyalgia | Phase 3 | Completed | Tonix Pharmaceuticals, Inc. | 457 | 2022-04-06 | 2025-01-22 |
| Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management Digital ACT, Digital Symptom Tracker - Fibromyalgia | Phase 3 | Completed | Swing Therapeutics, Inc. | 275 | 2022-02-08 | 2023-06-15 |
| Cannabidiol for Fibromyalgia (The CANNFIB Trial) Cannabidiol, Placebo - Fibromyalgia | Phase 3 | Completed | Marius Henriksen | 200 | 2021-03-01 | 2024-03-25 |
| Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial Transcutaneous Electrical Nerve Stimulation (TENS) with PT, PT only - Fibromyalgia | Phase 3 | Completed | Kathleen Sluka | 459 | 2021-01-22 | 2025-10-29 |
| A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia TNX-102 SL, Placebo SL Tablet - Fibromyalgia | Phase 3 | Completed | Tonix Pharmaceuticals, Inc. | 514 | 2020-07-22 | 2023-12-18 |
| The Innate Central Nervous System Immune Response to an Experimental Immune Challenge in People With Fibromyalgia Endotoxin, Escherichia Coli, Magnetic Resonance Spectroscopy - Fibromyalgia | Phase 2 / Phase 3 | Completed | University of Alabama at Birmingham | 36 | 2020-03-11 | 2023-04-14 |
| Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain Erenumab, Saline - Fibromyalgia | Phase 3 | Withdrawn | United States Naval Medical Center, Portsmouth | 2020-02-26 | 2025-08-14 | |
| A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia TNX-102 SL, Placebo SL Tablet - Fibromyalgia | Phase 3 | Completed | Tonix Pharmaceuticals, Inc. | 503 | 2019-12-09 | 2022-08-08 |
| LDN and tDCS in Fibromyalgia Low-Dose Naltrexone, Transcranial Direct Current Stimulation, Placebo - Fibromyalgia | Phase 2 / Phase 3 | Completed | Centro Universitario La Salle | 92 | 2018-08-01 | 2020-08-06 |
| Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia Duloxetine, Escitalopram - Fibromyalgia | Phase 2 / Phase 3 | Completed | Shaheed Zulfiqar Ali Bhutto Medical University | 200 | 2018-04-09 | 2020-02-27 |
| Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia TNX-102 SL Tablet, 2.8 mg, Placebo SL Tablet - Fibromyalgia, Myofascial Pain Syndromes | Phase 3 | Terminated | Tonix Pharmaceuticals, Inc. | 51 | 2016-07-22 | 2025-02-25 |
| The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia Pregabalin Release Tablets, Placebo - Fibromyalgia | Phase 3 | Unknown | Jiangsu HengRui Medicine Co., Ltd. | 240 | 2016-05-01 | 2016-08-16 |
| Cost-utility and Biological Underpinnings of MBSR in Fibromyalgia Syndrome MBSR, FibroQol, TAU - Fibromyalgia Syndrome | Phase 3 | Completed | Fundació Sant Joan de Déu | 225 | 2016-01-01 | 2019-10-14 |
| A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients TNX-102 SL Tablet 2.8 mg - Primary Fibromyalgia | Phase 3 | Completed | Tonix Pharmaceuticals, Inc. | 375 | 2015-08-04 | 2025-02-20 |
| Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease DS-5565, Placebo - Fibromyalgia | Phase 3 | Completed | Daiichi Sankyo | 56 | 2015-06-26 | 2020-11-24 |
| A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet - Fibromyalgia, Myofascial Pain Syndromes | Phase 3 | Completed | Tonix Pharmaceuticals, Inc. | 519 | 2015-04-01 | 2025-02-07 |
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Pain (18) · Chronic Pain (9) · Myalgia (4) · Arthralgia (3) · Depression (3) · Fatigue (3) · Musculoskeletal Diseases (3) · Osteoarthritis (3) · Arthritis (2) · Arthritis, Rheumatoid (2) · Fatigue Syndrome, Chronic (2) · Hyperalgesia (2) · Irritable Bowel Syndrome (2) · Muscular Diseases (2)
Muscular Diseases (95) · Nervous System Diseases (95) · Neuromuscular Diseases (95) · Rheumatic Diseases (95) · Musculoskeletal Diseases (94) · Pathological Conditions, Signs and Symptoms (34) · Signs and Symptoms (33) · Neurologic Manifestations (32) · Pain (11) · Joint Diseases (6) · Mental Disorders (6) · Pathologic Processes (6) · Behavior (5) · Skin and Connective Tissue Diseases (5) · Behavioral Symptoms (4)
Pregabalin (18) · Duloxetine Hydrochloride (10) · Milnacipran (9) · mirogabalin (5) · Sodium Oxybate (4) · Cognitive Behavioral Therapy (3) · O-methyl reboxetine (3) · esreboxetine (3) · Cannabidiol (2) · Gabapentin (2) · Lidocaine (2) · Sodium Chloride (2) · Sugars (2) · Transcranial Direct Current Stimulation (2) · cyclobenzaprine (2)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (13) · Tonix Pharmaceuticals, Inc. (8) · Eli Lilly and Company (7) · Daiichi Sankyo (5) · Forest Laboratories (5) · Jazz Pharmaceuticals (4) · Pfizer (4) · Wyeth is now a wholly owned subsidiary of Pfizer (3) · Axsome Therapeutics, Inc. (2) · Duke University (2) · Hospital de Clinicas de Porto Alegre (2) · Pierre Fabre Medicament (2) · University of Cincinnati (2) · University of Washington (2) · Aragon Institute of Health Sciences (1)
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Gregory Sullivan, MD (3) · Allan Spera (2) · Jennifer M Hootman, PhD (2) · Alejandro Gugliucci, MD, PhD (1) · Ashwin A Patkar, MD (1) · Benjamin H Natelson, MD (1) · Dana Dailey, PhD, PT (1) · Daniel J. Clauw, MD (1)
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