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Showing 1–24 of 34 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Cyclobenzaprine HCl Clear all
Terminated Phase 4 Interventional Results available

Cyclobenzaprine Extended Release (ER) for Fibromyalgia

NCT01041495
View directory record Official record
Conditions
Fibromyalgia, Pain, Sleep, Fatigue
Interventions
cyclobenzaprine ER (AMRIX), placebo
Drug
Lead sponsor
State University of New York - Upstate Medical University
Other
Eligibility
18 Years to 65 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
Syracuse, New York
Source: ClinicalTrials.gov public record
Updated Nov 26, 2024 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

NCT03508700
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL 5.6 mg
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
16
States / cities
Little Rock, Arkansas • Beverly Hills, California • Oceanside, California + 13 more
Source: ClinicalTrials.gov public record
Updated Feb 4, 2025 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

NCT04508621
View directory record Official record
Conditions
Fibromyalgia
Interventions
TNX-102 SL, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
514 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
36
States / cities
Birmingham, Alabama • Phoenix, Arizona • Oceanside, California + 33 more
Source: ClinicalTrials.gov public record
Updated Dec 17, 2023 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Use of Cyclobenzaprine After Vaginal Surgery

NCT01081990
View directory record Official record
Conditions
Postoperative Pain
Interventions
cyclobenzaprine
Drug
Lead sponsor
Endeavor Health
Other
Eligibility
18 Years to 70 Years · Female only
Enrollment
63 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2014
U.S. locations
1
States / cities
Evanston, Illinois
Source: ClinicalTrials.gov public record
Updated Sep 9, 2019 · Synced Sep 13, 2026, 5:13 PM EDT
Recruiting Phase 2 Interventional

A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

NCT07621237
View directory record Official record
Conditions
Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Depression
Interventions
TNX-102 SL, Placebo sublingual tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
360 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
25
States / cities
Phoenix, Arizona • Chino, California • Lemon Grove, California + 22 more
Source: ClinicalTrials.gov public record
Updated Jun 1, 2026 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 2Phase 3 Interventional Results available

BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

NCT01903265
View directory record Official record
Conditions
Primary Fibromyalgia
Interventions
TNX-102 SL 2.8mg, Placebo
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
17
States / cities
Sacramento, California • Denver, Colorado • Brooksville, Florida + 14 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2016 · Synced Sep 13, 2026, 5:13 PM EDT
Terminated Phase 4 Interventional

Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study

NCT02202369
View directory record Official record
Conditions
Single Level Lumbar Decompression and Fusion Spine Surgery
Interventions
Multimodal Analgesia Treatment, Standard of Care Pain Management Protocol
Other
Lead sponsor
OrthoCarolina Research Institute, Inc.
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
1
States / cities
Charlotte, North Carolina
Source: ClinicalTrials.gov public record
Updated May 21, 2026 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects

NCT07464535
View directory record Official record
Conditions
Healthy Subjects (HS)
Interventions
TNX-102 SL
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Cypress, California
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Driving Simulation to Assess Non-Sedative Effects of Tolperisone

NCT03353922
View directory record Official record
Conditions
Driving Impaired
Interventions
Cyclobenzaprine 10 Mg Oral Tablet, Placebo Oral Tablet
Drug
Lead sponsor
Neurana Pharmaceuticals, Inc.
Industry
Eligibility
21 Years to 55 Years
Enrollment
35 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2018
U.S. locations
2
States / cities
Long Beach, California • Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Jan 31, 2022 · Synced Sep 13, 2026, 5:13 PM EDT
Active, not recruiting Phase 4 Interventional

Multimodal Analgesia Effect on Post Surgical Patient

NCT04240626
View directory record Official record
Conditions
Obesity, Morbid, Surgery, Bariatric Surgery Candidate
Interventions
Neurontin, Dilaudid Injectable Product, Marcaine Injectable Product, Oxycodone Hydrochloride, Hycet 7.5Mg-325Mg/15Ml Solution, Zofran Injection, Scopolamine patch, Ativan, Flexeril Oral Product, Tylenol Suspension
Drug
Lead sponsor
University of California, Davis
Other
Eligibility
35 Years to 65 Years · Female only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Aug 7, 2025 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

NCT02589275
View directory record Official record
Conditions
Primary Fibromyalgia
Interventions
TNX-102 SL Tablet 2.8 mg
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
375 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
33
States / cities
Birmingham, Alabama • Phoenix, Arizona • Sacramento, California + 30 more
Source: ClinicalTrials.gov public record
Updated Feb 19, 2025 · Synced Sep 13, 2026, 5:13 PM EDT
Recruiting No phase listed Observational

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

NCT03511118
View directory record Official record
Conditions
Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI
Interventions
Tranexamic acid (TXA), labetalol, metformin, nifedipine, clindamycin, oxycodone, azithromycin, escitalopram, sertraline, ondansetron, Ciprofloxacin, Doxycycline, Levofloxacin, Methylphenidate, Sumatriptan, Citalopram, Cyclobenzaprine, Furosemide, Gabapentin, Hydrochlorothiazide, Hydroxyurea, Rosuvastatin, Topiramate, Trazodone, Valganciclovir, Venlafaxine, Verapamil, Remdesivir, Anakinra, Tocilizumab, Fluvoxamine, Amoxicillin, Bupropion, Duloxetine, Hydrocodone, Levetiracetam, Paroxetine, Buprenorphine
Drug
Lead sponsor
Duke University
Other
Eligibility
Not listed
Enrollment
1,600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2028
U.S. locations
20
States / cities
La Jolla, California • Loma Linda, California • Chicago, Illinois + 15 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2026 · Synced Sep 13, 2026, 5:13 PM EDT
Completed No phase listed Observational

Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study

NCT04771741
View directory record Official record
Conditions
Bunion of Unspecified Foot, Bunionette of Unspecified Foot, Hammertoe, Ankle Fractures, Achilles Tendon Surgery
Interventions
Acetominophen, Toradol, Meloxicam, Cyclobenzaprine, Lyrica
Drug
Lead sponsor
Prisma Health-Midlands
Other
Eligibility
18 Years to 99 Years
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Columbia, South Carolina
Source: ClinicalTrials.gov public record
Updated Apr 26, 2023 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

NCT05273749
View directory record Official record
Conditions
Fibromyalgia
Interventions
TNX-102 SL Tablet, 5.6 mg, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
457 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
33
States / cities
Phoenix, Arizona • Oceanside, California • Santa Ana, California + 30 more
Source: ClinicalTrials.gov public record
Updated Jan 21, 2025 · Synced Sep 13, 2026, 5:13 PM EDT
Recruiting Phase 2Phase 3 Interventional

Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

NCT07404397
View directory record Official record
Conditions
High Tone Pelvic Floor Dysfunction
Interventions
Cyclobenzaprine, Pelvic floor massage wand, Pelvic floor physical therapy
Drug · Device · Procedure
Lead sponsor
University of Michigan
Other
Eligibility
18 Years to 65 Years · Female only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Feb 19, 2026 · Synced Sep 13, 2026, 5:13 PM EDT
Terminated Phase 3 Interventional Results available

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

NCT03841773
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL, Placebo SL Tablets
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
192 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
30
States / cities
Phoenix, Arizona • Little Rock, Arkansas • Rogers, Arkansas + 27 more
Source: ClinicalTrials.gov public record
Updated Feb 5, 2025 · Synced Sep 13, 2026, 5:13 PM EDT
Terminated Phase 4 Interventional Results available

Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery

NCT04990804
View directory record Official record
Conditions
Opioid Use, Spinal Diseases, Surgery--Complications, Surgery, Postoperative Pain
Interventions
Opioid Analgesic, Opioid-Free Postoperative Pain Regimen
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 30, 2024 · Synced Sep 13, 2026, 5:13 PM EDT
Terminated Phase 2 Interventional Results available

Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients

NCT01921296
View directory record Official record
Conditions
Sleep Initiation and Maintenance Disorders, Pain
Interventions
Cyclobenzaprine
Drug
Lead sponsor
Lynn Henry
Other
Eligibility
18 Years and older · Female only
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Apr 19, 2016 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

NCT04172831
View directory record Official record
Conditions
Fibromyalgia
Interventions
TNX-102 SL, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
503 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
39
States / cities
Birmingham, Alabama • Phoenix, Arizona • Oceanside, California + 36 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2022 · Synced Sep 13, 2026, 5:13 PM EDT
Recruiting Phase 2 Interventional

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)

NCT06636786
View directory record Official record
Conditions
Acute Stress Reaction, Acute Stress Disorder, Neurocognitive Function, Post-traumatic Stress
Interventions
Cyclobenzaprine HCl, Placebo
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
18 Years to 55 Years
Enrollment
180 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
9
States / cities
Birmingham, Alabama • Indianapolis, Indiana • Kansas City, Kansas + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

NCT02436096
View directory record Official record
Conditions
Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases
Interventions
TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
519 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
35
States / cities
Birmingham, Alabama • Phoenix, Arizona • Sacramento, California + 31 more
Source: ClinicalTrials.gov public record
Updated Feb 6, 2025 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters

NCT01028014
View directory record Official record
Conditions
Urethral Sphincter Activity
Interventions
Pseudoephedrine, Tamsulosin, Imipramine, Cyclobenzaprine, Lactose capsule, Solifenacin
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
19 Years to 51 Years · Female only
Enrollment
56 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2011
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Jun 7, 2012 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

NCT04407377
View directory record Official record
Conditions
Healthy
Interventions
Tolperisone Hydrochloride, Cyclobenzaprine Hydrochloride 10 MG, Placebo
Drug · Other
Lead sponsor
Neurana Pharmaceuticals, Inc.
Industry
Eligibility
21 Years to 65 Years
Enrollment
39 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
2
States / cities
Long Beach, California • Berlin, New Jersey
Source: ClinicalTrials.gov public record
Updated Jan 31, 2022 · Synced Sep 13, 2026, 5:13 PM EDT
Completed Phase 2 Interventional Results available

Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions

NCT02421679
View directory record Official record
Conditions
PTSD
Interventions
TNX-102 SL
Drug
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
159 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
22
States / cities
Tuscaloosa, Alabama • Phoenix, Arizona • Imperial, California + 19 more
Source: ClinicalTrials.gov public record
Updated Feb 5, 2025 · Synced Sep 13, 2026, 5:13 PM EDT