Cyclobenzaprine

Generic Name: Cyclobenzaprine

Brand Names: Amrix, Fexmid, Flexeril

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₁N

CAS Number: 303-53-7

Unique Ingredient Identifier: 69O5WQQ5TI

Background: Cyclobenzaprine, a centrally-acting muscle relaxant, was first synthesized in 1961 and has been available for human use since 1977. It was initially studied for use as antidepressant given its structural similarity to tricyclic antidepressants - it differs from Amitriptyline by only a single double bond. Since its approval, it has remained relatively popular as an adjunctive, short-term treatment for acute skeletal muscle spasms secondary to musculoskeletal injury.

Indication: 用于缓解与急性疼痛的肌肉骨骼疾病相关的肌肉痉挛（作为休息和物理治疗的辅助药）。但环苯扎林对脑、脊髓疾病或儿童脑性瘫痪引起的痉挛无效。

Associated Conditions: Muscle Spasms

Clinical Trials

Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin

Phase 3

Completed

Conditions: Back Pain
Neck Pain
Spasm

Interventions: Drug: Cyclobenzaprine HCl
Drug: Placebo

First Posted Date: 2016-06-27

Last Posted Date: 2019-04-08

Lead Sponsor: Takeda

Target Recruit Count: 180

Registration Number: NCT02814565

Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

Phase 3

Conditions: Liver Cirrhosis

Interventions: Drug: Cyclobenzaprine
Drug: Calcium Carbonate

First Posted Date: 2015-12-30

Last Posted Date: 2018-01-03

Lead Sponsor: Tanta University

Target Recruit Count: 200

Registration Number: NCT02642861

Locations: 🇪🇬
Tanta university - faculty of medicine, Tanta, Egypt

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

Phase 2

Completed

Conditions: PTSD

Interventions: Drug: TNX-102 SL

First Posted Date: 2015-04-21

Last Posted Date: 2025-02-06

Lead Sponsor: Tonix Pharmaceuticals, Inc.

Target Recruit Count: 159

Registration Number: NCT02421679

Locations: 🇺🇸
Cns, Inc., Torrance, California, United States
🇺🇸
Sarkis Clinical Trials, Lake City, Florida, United States
🇺🇸
Compass Research North, LLC, Leesburg, Florida, United States

and more 19 locations

Prospective Analgesic Compound Efficacy (PACE) Study

Completed

Conditions: Radiculopathy
Gout
Muscle Spasms
Headache
Arthritis
Synovitis
Migraine
Tendonitis

First Posted Date: 2015-03-31

Last Posted Date: 2018-02-01

Lead Sponsor: Express Specialty Pharmacy

Target Recruit Count: 300

Registration Number: NCT02403687

Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

Phase 2

Completed

Conditions: PTSD

Interventions: Drug: Placebo
Drug: TNX-102 SL

First Posted Date: 2014-10-29

Last Posted Date: 2024-06-20

Lead Sponsor: Tonix Pharmaceuticals, Inc.

Target Recruit Count: 245

Registration Number: NCT02277704

Locations: 🇺🇸
University Hospitals Case Medical Center, Cleveland, Ohio, United States
🇺🇸
Altea Research, Las Vegas, Nevada, United States
🇺🇸
Cincinnati, Cincinnati, Ohio, United States

and more 20 locations

12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients

Phase 3

Completed

Conditions: Primary Fibromyalgia

Interventions: Drug: TNX-102 SL

First Posted Date: 2013-12-19

Last Posted Date: 2017-07-07

Lead Sponsor: Tonix Pharmaceuticals, Inc.

Target Recruit Count: 158

Registration Number: NCT02015234

Locations: 🇺🇸
71 Thomas Johnson Drive, Frederick, Maryland, United States
🇺🇸
370 Faunce Corner Road, North Dartmouth, Massachusetts, United States
🇺🇸
Jackson, Jackson, Mississippi, United States

and more 10 locations

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

Phase 2

Terminated

Conditions: Sleep Initiation and Maintenance Disorders
Pain

Interventions: Drug: Cyclobenzaprine

First Posted Date: 2013-08-13

Last Posted Date: 2016-04-20

Lead Sponsor: Lynn Henry

Target Recruit Count: 2

Registration Number: NCT01921296

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults

Phase 1

Completed

Conditions: Healthy Adults

Interventions: Drug: TNX-102 SL Tablets at 2.8 mg
Drug: Cyclobenzaprine tablets
Drug: TNX-102-B SL Tablets at 2.8 mg
Drug: TNX-102-C SL Tablets at 2.8 mg