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Cyclobenzaprine

Generic Name
Cyclobenzaprine
Brand Names
Amrix, Fexmid, Flexeril
Drug Type
Small Molecule
Chemical Formula
C20H21N
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

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

Phase 3
Terminated
Conditions
PTSD
Interventions
Drug: Placebo SL Tablets
First Posted Date
2019-02-15
Last Posted Date
2025-02-06
Lead Sponsor
Tonix Pharmaceuticals, Inc.
Target Recruit Count
192
Registration Number
NCT03841773
Locations
🇺🇸

Ashild Peters, Dallas, Texas, United States

Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
Drug: TNX-102 SL 5.6 mg
First Posted Date
2018-02-23
Last Posted Date
2018-04-24
Lead Sponsor
Tonix Pharmaceuticals, Inc.
Target Recruit Count
60
Registration Number
NCT03443960
Locations
🇨🇦

Quebec City, Quebec City, Quebec, Canada

Driving Simulation to Assess Non-Sedative Effects of Tolperisone

Phase 1
Completed
Conditions
Driving Impaired
Interventions
First Posted Date
2017-11-27
Last Posted Date
2022-02-01
Lead Sponsor
Neurana Pharmaceuticals, Inc.
Target Recruit Count
35
Registration Number
NCT03353922
Locations
🇺🇸

Collaborative Neuroscience Network, Long Beach, California, United States

🇺🇸

NeuroTrials Research, Atlanta, Georgia, United States

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

Phase 3
Terminated
Conditions
Pain, Acute
Interventions
Drug: Fixed Dose Combination
First Posted Date
2017-04-25
Last Posted Date
2023-02-09
Lead Sponsor
Apsen Farmaceutica S.A.
Target Recruit Count
140
Registration Number
NCT03127592
Locations
🇧🇷

Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda., Valinhos, São Paulo, Brazil

12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

Phase 3
Terminated
Conditions
PTSD
Interventions
First Posted Date
2017-04-12
Last Posted Date
2025-02-06
Lead Sponsor
Tonix Pharmaceuticals, Inc.
Target Recruit Count
190
Registration Number
NCT03110575
Locations
🇺🇸

New York, New York, New York, United States

🇺🇸

Orange, Orange, California, United States

🇺🇸

Rogers, Rogers, Arkansas, United States

and more 28 locations

Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

Phase 3
Terminated
Conditions
PTSD
Interventions
Drug: Placebo SL Tablet
First Posted Date
2017-02-23
Last Posted Date
2024-05-22
Lead Sponsor
Tonix Pharmaceuticals, Inc.
Target Recruit Count
358
Registration Number
NCT03062540
Locations
🇺🇸

Chicago, Chicago, Illinois, United States

🇺🇸

Lauderhill, Lauderhill, Florida, United States

🇺🇸

Maitland, Maitland, Florida, United States

and more 40 locations

Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment

Phase 3
Completed
Conditions
Musculoskeletal Pain
Interventions
First Posted Date
2017-01-19
Last Posted Date
2021-02-24
Lead Sponsor
EMS
Target Recruit Count
416
Registration Number
NCT03025113
Locations
🇧🇷

Allegisa, Campinas, São Paulo, Brazil

Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders

Not Applicable
Completed
Conditions
Temporomandibular Disorder
Interventions
Other: Osteopathic Group
Other: Conventional Group
First Posted Date
2016-11-28
Last Posted Date
2016-11-28
Lead Sponsor
Instituto Brasileiro de Osteopatia
Target Recruit Count
32
Registration Number
NCT02974166
Locations
🇧🇷

Brazilian Institute of Osteopathy, Porto Alegre, Rio Grande do Sul, Brazil

Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment

First Posted Date
2016-08-11
Last Posted Date
2020-04-02
Lead Sponsor
EMS
Target Recruit Count
414
Registration Number
NCT02862977
Locations
🇧🇷

Marcio Antonio Pereira Clinica de Endocrinologia, São José dos Campos, São Paulo, Brazil

🇧🇷

Associação dos funcionários públicos do estado do RGS, Porto Alegre, RS, Brazil

🇧🇷

Centro de Medicina Reprodutiva Dr Carlos Isaia Filho, Porto Alegre, RS, Brazil

and more 3 locations
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