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59 results

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Page 1
Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double-Blind, Placebo-Controlled Trial.
Lederman S, Arnold LM, Vaughn B, Kelley M, Sullivan GM. Lederman S, et al. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2359-2368. doi: 10.1002/acr.25142. Epub 2023 Jul 4. Arthritis Care Res (Hoboken). 2023. PMID: 37165930 Clinical Trial.
OBJECTIVE: To evaluate the efficacy and safety of TNX-102 SL, a once-nightly sublingual formulation of cyclobenzaprine, in reducing pain in patients with fibromyalgia (FM). METHODS: RELIEF was a double-blind, randomized, placebo-controlled trial. ...
OBJECTIVE: To evaluate the efficacy and safety of TNX-102 SL, a once-nightly sublingual formulation of cyclobenzaprine, in reducing p …
Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine.
Lederman S, Arnold LM, Vaughn B, Engels JM, Kelley M, Sullivan GM. Lederman S, et al. Pain Med. 2026 Jan 1;27(1):86-94. doi: 10.1093/pm/pnaf089. Pain Med. 2026. PMID: 40627411 Free PMC article. Clinical Trial.
We evaluated efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg for treatment of fibromyalgia. METHODS: This phase 3, double-blind, multicenter, placebo-controlled trial randomized patients 1:1 to once-nightly TNX-102 SL 2.8 mg for 2 weeks, follo …
We evaluated efficacy and safety of bedtime TNX-102 SL (sublingual cyclobenzaprine) 5.6 mg for treatment of fibromyalgia. METHODS: Th …
Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response.
Sullivan GM, Gendreau RM, Gendreau J, Peters P, Peters A, Engels J, Daugherty BL, Vaughn B, Weathers FW, Lederman S. Sullivan GM, et al. Psychiatry Res. 2021 Jul;301:113974. doi: 10.1016/j.psychres.2021.113974. Epub 2021 Apr 30. Psychiatry Res. 2021. PMID: 33979763 Free article. Clinical Trial.
This 12-week randomized multicenter trial evaluated efficacy and safety of TNX-102 SL, a bedtime sublingual formulation of cyclobenzaprine, in patients with military-related PTSD randomized to TNX-102 SL 2.8 mg or 5.6 mg, or placebo. ...
This 12-week randomized multicenter trial evaluated efficacy and safety of TNX-102 SL, a bedtime sublingual formulation of cyclobenzaprin …
Comparison of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia. A randomized, double-blind clinical trial.
Carette S, Bell MJ, Reynolds WJ, Haraoui B, McCain GA, Bykerk VP, Edworthy SM, Baron M, Koehler BE, Fam AG, et al. Carette S, et al. Arthritis Rheum. 1994 Jan;37(1):32-40. doi: 10.1002/art.1780370106. Arthritis Rheum. 1994. PMID: 8129762 Clinical Trial.
OBJECTIVE: To compare the relative efficacy and tolerability of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia, and to identify predictors of response to amitriptyline and cyclobenzaprine. METHODS: Two hundred eight patients who fulfill …
OBJECTIVE: To compare the relative efficacy and tolerability of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibro …
Patient education and self-care for the management of jaw pain upon awakening: a randomized controlled clinical trial comparing the effectiveness of adding pharmacologic treatment with cyclobenzaprine or tizanidine.
Alencar FG Jr, Viana PG, Zamperini C, Becker A. Alencar FG Jr, et al. J Oral Facial Pain Headache. 2014 Spring;28(2):119-27. doi: 10.11607/ofph.963. J Oral Facial Pain Headache. 2014. PMID: 24822235 Clinical Trial.
AIMS: To compare the effectiveness of adding cyclobenzaprine, tizanidine, or placebo to patient education and a self-care management program for patients with myofascial pain and specifically presenting with jaw pain upon awakening. ...CONCLUSION: The use of tizanidine or …
AIMS: To compare the effectiveness of adding cyclobenzaprine, tizanidine, or placebo to patient education and a self-care management …
The effectiveness of adding pharmacologic treatment with clonazepam or cyclobenzaprine to patient education and self-care for the treatment of jaw pain upon awakening: a randomized clinical trial.
Herman CR, Schiffman EL, Look JO, Rindal DB. Herman CR, et al. J Orofac Pain. 2002 Winter;16(1):64-70. J Orofac Pain. 2002. PMID: 11889661 Clinical Trial.

Between-group differences demonstrated a statistically significant difference (P < .016) between cyclobenzaprine and placebo, and between cyclobenzaprine and clonazepam. There was no significant effect on sleep quality in any group. CONCLUSION: This study suggest

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Between-group differences demonstrated a statistically significant difference (P < .016) between cyclobenzaprine and placebo, and

…
A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder.
Parmenter ME, Lederman S, Weathers FW, Davis LL, Vaughn B, Engels J, Sullivan GM. Parmenter ME, et al. Psychiatry Res. 2024 Apr;334:115764. doi: 10.1016/j.psychres.2024.115764. Epub 2024 Feb 1. Psychiatry Res. 2024. PMID: 38350291 Free article. Clinical Trial.
TNX-102 SL is a bedtime sublingual formulation of cyclobenzaprine with potent binding and antagonist activity at 5-HT(2A), alpha(1)-adrenergic, H(1) histaminergic, and M(1) muscarinic receptors, which play roles in the pharmacological management of sleep disturbances. ...
TNX-102 SL is a bedtime sublingual formulation of cyclobenzaprine with potent binding and antagonist activity at 5-HT(2A), alpha(1)-a …
Cyclobenzaprine with ibuprofen versus ibuprofen alone in acute myofascial strain: a randomized, double-blind clinical trial.
Turturro MA, Frater CR, D'Amico FJ. Turturro MA, et al. Ann Emerg Med. 2003 Jun;41(6):818-26. doi: 10.1067/mem.2003.188. Ann Emerg Med. 2003. PMID: 12764337 Clinical Trial.
STUDY OBJECTIVE: We evaluate the analgesic and side effects of adding cyclobenzaprine to ibuprofen in emergency department patients with acute myofascial strain. ...In addition, 51 patients received a single dose of 10 mg of cyclobenzaprine and a vial of 6 capsules …
STUDY OBJECTIVE: We evaluate the analgesic and side effects of adding cyclobenzaprine to ibuprofen in emergency department patients w …
Cyclobenzaprine and naproxen versus naproxen alone in the treatment of acute low back pain and muscle spasm.
Borenstein DG, Lacks S, Wiesel SW. Borenstein DG, et al. Clin Ther. 1990 Mar-Apr;12(2):125-31. Clin Ther. 1990. PMID: 2141299 Clinical Trial.
Two groups of 20 patients each, with mild to moderate acute low back pain with associated muscle spasm of ten days' duration or less, were treated with a combination of cyclobenzaprine and naproxen or naproxen alone in a randomized, 14-day open-label trial. Cyclobenzapr …
Two groups of 20 patients each, with mild to moderate acute low back pain with associated muscle spasm of ten days' duration or less, were t …
Pharmacokinetics and bioequivalence evaluation of cyclobenzaprine tablets.
Brioschi TM, Schramm SG, Kano EK, Koono EE, Ching TH, Serra CH, Porta V. Brioschi TM, et al. Biomed Res Int. 2013;2013:281392. doi: 10.1155/2013/281392. Epub 2013 Sep 16. Biomed Res Int. 2013. PMID: 24151591 Free PMC article. Clinical Trial.
The purpose of this study was to investigate cyclobenzaprine pharmacokinetics and to evaluate bioequivalence between two different tablet formulations containing the drug. ...Cyclobenzaprine plasma profiles for the reference and test products were similar, as well a …
The purpose of this study was to investigate cyclobenzaprine pharmacokinetics and to evaluate bioequivalence between two different ta …
59 results