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Axert (Almotriptan Malate) - Summary

 



AXERT SUMMARY

AXERT®
(almotriptan malate) Tablets

AXERT Tablets contain almotriptan malate, a selective 5-hydroxytryptamine1B/1D(5-HT1B/1D) receptor agonist.

AXERT Tablets are indicated for the acute treatment of migraine with or without aura in adults.

AXERT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of AXERT have not been established for cluster headache, which is present in an older, predominantly male population.


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NEWS HIGHLIGHTS

Media Articles Related to Axert (Almotriptan)

Migraine Raises Risk Of Most Common Form Of Stroke
Source: Headache / Migraine News From Medical News Today [2009.11.17]
Pooling results from 21 studies, involving 622,381 men and women, researchers at Johns Hopkins have affirmed that migraine headaches are associated with more than twofold higher chances of the most common kind of stroke: those occurring when blood supply to the brain is suddenly cut off by the buildup of plaque or a blood clot. The risk for those with migraines is 2.3 times those without, according to calculations from the Johns Hopkins team, to be presented Nov.

Migraine Increases Likelihood of Stroke
Source: MedicineNet Birth Control Specialty [2009.11.17]
Title: Migraine Increases Likelihood of Stroke
Category: Health News
Created: 11/16/2009 12:10:00 PM
Last Editorial Review: 11/17/2009

Molecular Imaging Pinpoints Inflammation In The Brains Of Schizophrenics And Migraine Sufferers
Source: Headache / Migraine News From Medical News Today [2009.11.02]
Inflammatory response of brain cells - as indicated by a molecular imaging technique - could tell researchers more about why certain neurologic disorders, such as migraine headaches and psychosis in schizophrenic patients, occur and provide insight into how to best treat them, according to two studies published in the November issue of The Journal of Nuclear Medicine.

Migraine With Aura Is Associated With Increased Risk Of Stroke
Source: Headache / Migraine News From Medical News Today [2009.10.29]
A migraine with aura occurs when temporary visual or sensory disturbances are experienced before or during a migraine headache. A study just published on bmj.com reports that migraine with aura is associated with a twofold increased risk of stroke. Further risk factors for stroke among patients with migraine are being a woman, being young, being a smoker, and using contraceptives containing estrogen.

Migraine With Aura Doubles The Risk Of Stroke
Source: Headache / Migraine News From Medical News Today [2009.10.28]
Migraine with aura (temporary visual or sensory disturbances before or during a migraine headache) is associated with a twofold increased risk of stroke, finds a study published on bmj.com today. Further risk factors for stroke among patients with migraine are being a woman, being young, being a smoker, and using oestrogen containing contraceptives.

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Published Studies Related to Axert (Almotriptan)

Migraine treatment with rizatriptan and almotriptan: a crossover study. [2009.05]
BACKGROUND: Rizatriptan and almotriptan are effective and well-tolerated triptans that have not been compared directly. OBJECTIVE: To evaluate the effectiveness of rizatriptan 10 mg and almotriptan for the acute treatment of migraine, in a real-world setting... CONCLUSIONS: Times to achieve PR and PF were significantly shorter for patients using rizatriptan, as compared with those using almotriptan.

Efficacy and tolerability of almotriptan in adolescents: a randomized, double-blind, placebo-controlled trial. [2008.10]
OBJECTIVES: To assess the efficacy and safety of almotriptan 6.25 mg, 12.5 mg, and 25 mg vs placebo for acute migraine treatment in adolescents... CONCLUSIONS: Oral almotriptan was efficacious for relieving migraine headache pain in adolescents, with the 12.5-mg dose associated with the most favorable efficacy profile with respect to relieving headache pain and associated symptoms of migraine (photophobia and phonophobia). Almotriptan treatment was well tolerated in this adolescent population.

Efficacy and Tolerability of Almotriptan in Adolescents: A Randomized, Double-Blind, Placebo-Controlled Trial. [2008.05.14]
Objectives.- To assess the efficacy and safety of almotriptan 6.25 mg, 12.5 mg, and 25 mg vs placebo for acute migraine treatment in adolescents. Patients and Methods.- In this double-blind, placebo-controlled, parallel-group, multicenter trial, 866 patients aged 12 to 17 years with a >1 year history of migraine (per International Headache Society criteria) were randomized to treat one migraine headache with almotriptan 6.25 mg, 12.5 mg, 25 mg, or placebo...

Early vs. non-early intervention in acute migraine-'Act when Mild (AwM)'. A double-blind, placebo-controlled trial of almotriptan. [2008.04]
The study was designed to compare the response to almotriptan in migraine patients who take medication early in the course of the attack with that when medication is taken after pain has become moderate or severe. A randomized, four-arm, multicentre, multinational, double-blind, placebo-controlled trial of almotriptan (12.5 mg) comparing treatment administration when pain intensity was mild and within 1 h of headache onset vs...

Early intervention with almotriptan: results of the AEGIS trial (AXERT Early Migraine Intervention Study). [2007.02]
OBJECTIVE: To evaluate prospectively the efficacy and safety of almotriptan 12.5 mg as compared to placebo when administered within 1 hour of headache pain onset for the acute treatment of 3 migraine headaches. BACKGROUND: Although clinical trials have reported improved outcomes when triptans were used early or to treat mild pain, acceptance of this treatment strategy has been hampered by both efficacy and tolerability issues... CONCLUSION: Treatment with almotriptan within 1 hour of migraine onset resulted in significantly better clinical outcomes than placebo and tolerability similar to placebo. Acute medications, such as almotriptan, that are both effective and well tolerated may encourage patients to access acute treatment earlier.

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Clinical Trials Related to Axert (Almotriptan)

The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain [Completed]
The purpose of this study is to evaluate the effectiveness and safety of AXERT when treating a migraine at the onset of headache pain, as compared to treating a migraine only after the headache pain has reached at least moderate intensity..

A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache [Completed]
The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) 12. 5 milligram tablets compared with placebo for the acute treatment of migraine headache at the earliest onset of headache pain. Almotriptan malate (AXERT®) is approved for the treatment of migraine headache, with or without aura, in adults. Patients in this study will take either almotriptan or placebo oral tablets for 3 consecutive migraine headaches.

A Study of 3 Dosage Strengths of Aalmotriptan Malate (AXERT®) in the Treatment of Acute Migraine in Adolescents [Completed]
The purpose of this study is to evaluate the effectiveness and safety of almotriptan malate (AXERT®) in treating acute migraine headaches in adolescents. Amotriptan malate (AXERT®) is approved for use in the treatment of acute migraine headache with or without aura in adults. In this study, adolescents will be given a single dose of study medication to treat one migraine headache..

Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine [Completed]
The purpose of this study is to evaluate the impact of topiramate (migraine prevention medicine) on the effectiveness of almotriptan malate (acute migraine medicine) when treating acute migraine headaches.

Standardized sTudy With Almotriptan in eaRly Treatment of Migraine [Recruiting]
This is a observational, open, prospective, single arm cohort study within authorized SPC conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.

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Page last updated: 2009-11-17

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