24 completed, 6 recruiting, 5 terminated, 2 not yet recruiting. 13 Phase 3, 10 Phase 1, 6 Phase 4, 5 Phase 2, 4 Not applicable.
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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 |
|---|---|---|---|---|---|---|
| An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service TPS-Select, Pharmacologic Pain Management, Interventional Pain Procedures - Postsurgical Pain Management, Postsurgical Pain, Chronic | Phase 3 | Not yet recruiting | University of California, San Francisco | 474 | 2026-10-01 | 2026-10-09 |
| Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release Bupivicaine, Fentanyl, Thoracic epidural analgesia - Ventral Hernia, Ventral Hernia Repair | Phase 4 | Recruiting | Northwestern University | 40 | 2026-09-25 | 2026-10-07 |
| Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy Cyclobenzaprine - Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified | Phase 4 | Not yet recruiting | Christiana Care Health Services | 36 | 2026-07-01 | 2026-06-24 |
| A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) TNX-102 SL, Placebo sublingual tablet - Major Depressive Episode (MDE), Major Depressive Disorder (MDD) | Phase 2 | Recruiting | Tonix Pharmaceuticals, Inc. | 360 | 2026-06-25 | 2026-09-25 |
| Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil FDC of etoricoxib + cyclobenzaprine + etoricoxib placebo, etoricoxib 90 mg (Arcoxia®) +FDC placebo, cyclobenzaprine hydrochloride + etoricoxib placebo - Third Molar Extraction | Phase 3 | Withdrawn | Eurofarma Laboratorios S.A. | 2026-05-30 | 2024-02-28 | |
| Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction Cyclobenzaprine, Pelvic floor massage wand, Pelvic floor physical therapy - High Tone Pelvic Floor Dysfunction | Phase 2 / Phase 3 | Recruiting | University of Michigan | 60 | 2026-02-18 | 2026-02-20 |
| Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) Cyclobenzaprine HCl, Placebo - Acute Stress Reaction, Acute Stress Disorder | Phase 2 | Recruiting | University of North Carolina, Chapel Hill | 180 | 2025-03-25 | 2026-10-22 |
| Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below., Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below., Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below. - Low Back Pain, Myofascial Pain Syndrome Lower Back | Phase 4 | Recruiting | Madigan Army Medical Center | 180 | 2020-12-28 | 2021-01-12 |
| Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study Acetominophen, Toradol, Meloxicam - Bunion of Unspecified Foot, Bunionette of Unspecified Foot | Completed | Prisma Health-Midlands | 72 | 2020-12-01 | 2023-04-27 | |
| Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction Fixed Dose Combination, Etodolac, Cyclobenzaprine - Pain, Acute | Phase 3 | Terminated | Apsen Farmaceutica S.A. | 140 | 2020-10-05 | 2026-09-09 |
| Effects of Tolperisone on Measures of Drowsiness and Cognitive Function Tolperisone Hydrochloride, Cyclobenzaprine Hydrochloride 10 MG, Placebo - Healthy | Phase 1 | Completed | Neurana Pharmaceuticals, Inc. | 39 | 2020-06-20 | 2022-02-01 |
| Dose-Proportionality and Food Effect Study of TNX-102 SL TNX-102 SL - Healthy Subjects | Phase 1 | Completed | Tonix Pharmaceuticals, Inc. | 16 | 2019-10-14 | 2020-01-06 |
| Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants Tranexamic acid (TXA), labetalol, metformin - Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI | Recruiting | Duke University | 1600 | 2018-10-04 | 2026-07-29 | |
| Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis Cyclobenzaprine, Calcium Carbonate - Liver Cirrhosis | Phase 3 | Unknown | Tanta University | 200 | 2018-10-01 | 2018-01-03 |
| Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment ketoprofen and cyclobenzaprine association, Cyclobenzaprine - Musculoskeletal Pain | Phase 3 | Completed | EMS | 416 | 2018-03-08 | 2021-02-24 |
| Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules TNX-102 SL 5.6 mg, Amrix 30 mg - Healthy Subjects | Phase 1 | Completed | Tonix Pharmaceuticals, Inc. | 60 | 2018-01-29 | 2018-04-24 |
| Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment ketoprofen and cyclobenzaprine association with caffeine, Cyclobenzaprine with caffeine - Musculoskeletal Pain | Phase 3 | Completed | EMS | 414 | 2017-11-10 | 2020-04-02 |
| Driving Simulation to Assess Non-Sedative Effects of Tolperisone Cyclobenzaprine 10 Mg Oral Tablet, Placebo Oral Tablet - Driving Impaired | Phase 1 | Completed | Neurana Pharmaceuticals, Inc. | 35 | 2017-07-31 | 2022-02-01 |
| 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients TNX-102 SL - PTSD | Phase 3 | Terminated | Tonix Pharmaceuticals, Inc. | 190 | 2017-06-20 | 2025-02-06 |
| Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin Cyclobenzaprine HCl, Placebo - Neck Pain, Back Pain | Phase 3 | Completed | Takeda | 180 | 2016-10-12 | 2019-04-08 |
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Pain (4) · Fibromyalgia (3) · Pain, Postoperative (3) · Spasm (3) · Depression (2) · Low Back Pain (2) · Migraine Disorders (2) · Musculoskeletal Pain (2) · Acute Pain (1) · Adenomyosis (1) · Adnexal Diseases (1) · Agnosia (1) · Ankle Fractures (1) · Arthritis (1) · Back Pain (1)
Tonix Pharmaceuticals, Inc. (11) · EMS (2) · Eurofarma Laboratorios S.A. (2) · Neurana Pharmaceuticals, Inc. (2) · Apsen Farmaceutica S.A. (1) · Christiana Care Health Services (1) · Duke University (1) · Endeavor Health (1) · Express Specialty Pharmacy (1) · Instituto Brasileiro de Osteopatia (1) · Kennedy Medical Group (1) · Lynn Henry (1) · Madigan Army Medical Center (1) · McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. (1) · Montefiore Medical Center (1)
United States (21) · Canada (8) · Brazil (6) · Egypt (1) · India (1) · Russia (1)
Denis Audet, MD (6) · Jeffrey P. Kitrelle, MD (3) · Seth M. Lederman, MD (3) · A. Orson Brod, M.D. (1) · Alceu Chueiri (1) · Andrew Bishara, MD (1) · Antonio Carlos Ximenes (1) · Antonio Scotton (1) · Carlos Roberto Galia (1) · Christopher Jones, MD (1) · Denise Bedoya (1) · Gregory Sullivan (1) · Holly E Richter, PhD, MD (1)