scholarly journals A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Tolerability, and Safety of Celecoxib Oral Solution (ELYXYB) in Acute Treatment of Episodic Migraine with or without Aura

2021 ◽  
Vol Volume 14 ◽  
pp. 2529-2542
Author(s):  
Richard B Lipton ◽  
Sagar Munjal ◽  
Stewart J Tepper ◽  
Charles Iaconangelo ◽  
Daniel Serrano
Keyword(s):  
Acute Treatment ◽  
Episodic Migraine ◽  
Oral Solution ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Tolerability, and Safety of Celecoxib Oral Solution (ELYXYB) in Acute Treatment of Episodic Migraine With or Without Aura

2021 ◽  
Author(s):  
Richard B Lipton ◽  
Sagar Munjal ◽  
Stewart J Tepper ◽  
Charles Iaconangelo ◽  
Daniel Serrano
Keyword(s):  
Acute Treatment ◽  
Study Drug ◽  
Response Rates ◽  
Episodic Migraine ◽  
Oral Solution ◽  
Phase Iii ◽  
Controlled Study ◽  
Post Dose ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background Safe, effective, oral therapies are needed for acute treatment of migraine. This clinical trial assessed the efficacy, tolerability, and safety of celecoxib oral solution (ELYXYB) in a single migraine attack associated with moderate-to-severe pain. Methods This Phase III, randomized, double-blind, placebo-controlled, multicenter trial treated adults with episodic migraine (with or without aura) with a single 4.8 mL dose of 120-mg celecoxib oral solution or placebo. Co-primary endpoints were the proportion of patients who were pain-free and free from the most bothersome migraine symptom (MBS) at 2 hours post-dose. The MBS was identified at screening from among nausea, photophobia, or phonophobia. Results Six hundred thirty-one patients were randomized (mean age 41 years, range 18–75; 84.3% female). One study site met prespecified outlier criteria and was excluded from efficacy analyses. This site had a mean 2-hour pain freedom placebo response rate of 75% vs 23.5% for all other sites. In subsequent analysis, 2-hour post-dose pain freedom response rates were significantly higher in the celecoxib oral solution group vs placebo (32.8%, [27.2%, 38.8%]) vs 23.5%, [18.5%, 29.2%]; P = 0.020). For 2-hour post-dose MBS freedom, response rates were significantly higher in the celecoxib oral solution group vs placebo (58.1% [51.4%, 64.5%] vs 43.9% [37.2%, 50.7%]; P = 0.003). A total of 10.7% (31/289) of patients treated with celecoxib oral solution and 9.9% (28/283) of placebo-treated patients reported a treatment-emergent adverse event (TEAE). Study drug-related TEAEs were reported by 7.3% (21/289) and 7.4% (21/283) of celecoxib oral solution and placebo patients, respectively; the most common were nausea (celecoxib oral solution: 1.4% [4/289] vs placebo: 1.8% [5/283]) and dysgeusia (celecoxib oral solution: 1.7% [5/289] vs placebo: 1.1% [3/283]). No serious TEAEs, deaths, or drug-related TEAEs leading to withdrawal were reported. Conclusions Celecoxib oral solution is a safe, effective COX-2-selective nonsteroidal anti-inflammatory drug for the treatment of acute migraine. In this analysis, celecoxib oral solution was significantly more effective than placebo and was also associated with a low rate of gastric TEAEs. Celecoxib oral solution may provide a convenient, alternate option to currently available treatments. Trial registration: ClinicalTrials.gov Identifier: NCT03009019; Registered January 4, 2017; Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03009019

Rupatadine oral solution in children with persistent allergic rhinitis: A randomized, double-blind, placebo-controlled study

2013 ◽  
Vol 24 (2) ◽  
pp. 144-150 ◽  
Author(s):  
Paul Potter ◽  
Jorge F. Maspero ◽  
Jan Vermeulen ◽  
László Barkai ◽  
Ildikó Németh ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Oral Solution ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Persistent Allergic Rhinitis

Rizatriptan 5 mg for the Acute Treatment of Migraine in Adolescents: A Randomized, Double-Blind, Placebo-Controlled Study

2002 ◽  
Vol 42 (1) ◽  
pp. 49-55 ◽  
Author(s):  
Paul Winner ◽  
Donald Lewis ◽  
W. Hester Visser ◽  
Kaihong Jiang ◽  
Suzanne Ahrens ◽  
...  
Keyword(s):  
Acute Treatment ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Acute treatment with the PDE4 inhibitor roflumilast improves verbal word memory in healthy old individuals: a double-blind placebo-controlled study

2019 ◽  
Vol 77 ◽  
pp. 37-43 ◽  
Author(s):  
Arjan Blokland ◽  
Marlies A. Van Duinen ◽  
Anke Sambeth ◽  
Pim R.A. Heckman ◽  
Max Tsai ◽  
...  
Keyword(s):  
Acute Treatment ◽  
Pde4 Inhibitor ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Word Memory

scholarly journals Oral lysine clonixinate in the acute treatment of migraine: a double-blind placebo-controlled study

2001 ◽  
Vol 59 (1) ◽  
pp. 46-49 ◽  
Author(s):  
Abouch V. Krymchantowski ◽  
Jackeline S. Barbosa ◽  
Celia Cheim ◽  
Luiz A. Alves
Keyword(s):  
Placebo Group ◽  
Acute Treatment ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pain Syndromes ◽  
Severe Intensity ◽  
Ihs Criteria ◽  
Lysine Clonixinate ◽  
Severe Migraine

Several oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective to treat migraine attacks. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has proven to be effective in various pain syndromes such as renal colic and muscular pain. The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of oral LC compared to placebo in the acute treatment of migraine. Sixty four patients with the diagnosis of migraine, according to the IHS criteria, were studied prospectively. Patients received LC or placebo once the headache reached moderate or severe intensity for 6 consecutive attacks. With regard to the moderate attacks, LC was superior than placebo after 1, 2 and 4 hours. The consumption of other rescue medications after 4 hours was significantly higher in the placebo group. With regard to the severe attacks, there was no difference between the active drug group and the placebo group concerning headache intensity and consumption of other rescue medications. We conclude that the NSAID lysine clonixinate is effective in treating moderately severe migraine attacks. It is not superior than placebo in treating severe migraine attacks.

Effects on Migraine Headache of MDL 72,222, an Antagonist at Neuronal 5-HT Receptors. Double-Blind, Placebo-Controlled Study

Cephalalgia ◽  
1985 ◽  
Vol 5 (2) ◽  
pp. 79-82 ◽  
Author(s):  
Claude Loisy ◽  
Sylvain Beorchia ◽  
Vincenzo Centonze ◽  
John R Fozard ◽  
Paul J Schechter ◽  
...  
Keyword(s):  
Migraine Headache ◽  
Acute Treatment ◽  
Mixed Type ◽  
Therapeutic Agents ◽  
Controlled Study ◽  
Antagonist Activity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Migraine Pain ◽  
Novel Agent

MDL 72,222 (1aH, 5aH-tropan-3a-yl 3,5-dichlorobenzoate), a novel agent with antagonist activity at neuronal 5-HT receptors, was tested as an acute treatment for migraine pain under double-blind, placebo-controlled conditions. Forty-seven patients with common ( n = 29) or classical ( n = 8) migraine or mixed type with or without a psychogenic component ( n = 10) received 20–40 mg MDL 72,222 ( n = 24) or placebo ( n = 23) intravenously during the headache phase of a migraine attack. MDL 72,222 was consistently superior to placebo in rapidly alleviating the migraine pain. The treatment was remarkably well tolerated. The results are consistent with the hypothesis that the pain of migraine is related to activation of neuronal 5-HT receptors and suggest that compounds such as MDL 72,222, which block neuronal 5-HT receptors, could be useful new therapeutic agents for the management of migraine.

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