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Last Updated: March 4, 2021

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CLINICAL TRIALS PROFILE FOR CYCLOBENZAPRINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Cyclobenzaprine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01490788 Comparative Bioavailability of TNX-102 and Cyclobenzaprine and Effect of Food on the Pharmacokinetics of TNX-102 in Healthy Adults Completed Tonix Pharmaceuticals, Inc. Phase 1 2011-12-01 Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.
New Formulation NCT01634412 Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults Completed Tonix Pharmaceuticals, Inc. Phase 1 2012-06-01 Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of sublingual TNX-102 2.4 mg (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at pH 3.5 and 7.1 and to compare the bio-availability of sublingual TNX-102 2.4 mg at pH 3.5 and 7.1 and cyclobenzaprine (5 mg tablets, or 2.4 mg iv).
New Formulation NCT01689259 Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults Completed Tonix Pharmaceuticals, Inc. Phase 1 2012-09-01 Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cyclobenzaprine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00246389 An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Phase 4 1969-12-31 The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.
NCT00610610 Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome Completed GlaxoSmithKline Phase 4 2002-01-01 Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00610610 Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome Completed Duke University Phase 4 2002-01-01 Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cyclobenzaprine Hydrochloride

Condition Name

Condition Name for Cyclobenzaprine Hydrochloride
Intervention Trials
Healthy Adults 4
Primary Fibromyalgia 4
Pain 3
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Condition MeSH

Condition MeSH for Cyclobenzaprine Hydrochloride
Intervention Trials
Myofascial Pain Syndromes 9
Fibromyalgia 9
Low Back Pain 5
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Clinical Trial Locations for Cyclobenzaprine Hydrochloride

Trials by Country

Trials by Country for Cyclobenzaprine Hydrochloride
Location Trials
United States 122
Canada 7
Brazil 7
Russian Federation 5
India 2
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Trials by US State

Trials by US State for Cyclobenzaprine Hydrochloride
Location Trials
California 8
Florida 7
New York 7
Washington 6
Ohio 6
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Clinical Trial Progress for Cyclobenzaprine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Cyclobenzaprine Hydrochloride
Clinical Trial Phase Trials
Phase 4 6
Phase 3 14
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Cyclobenzaprine Hydrochloride
Clinical Trial Phase Trials
Completed 15
Not yet recruiting 6
Recruiting 4
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Clinical Trial Sponsors for Cyclobenzaprine Hydrochloride

Sponsor Name

Sponsor Name for Cyclobenzaprine Hydrochloride
Sponsor Trials
Tonix Pharmaceuticals, Inc. 14
EMS 2
Neurana Pharmaceuticals, Inc. 2
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Sponsor Type

Sponsor Type for Cyclobenzaprine Hydrochloride
Sponsor Trials
Industry 31
Other 14
U.S. Fed 1
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