Axert (Almotriptan Malate) - Summary

AXERT SUMMARY

AXERT^®
(almotriptan malate) Tablets

AXERT Tablets contain almotriptan malate, a selective 5-hydroxytryptamine_1B/1D(5-HT_1B/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 With Aura: Magnetic Stimulation Is A Promising Non-Drug Treatment Option
Source: Headache / Migraine News From Medical News Today [2010.03.04]
An article published Online First and in the April edition of The Lancet Neurology reports that a new hand-held device that delivers a magnetic pulse to the back of the head could be a promising non-invasive, non-drug treatment option for patients with migraine. This device offers efficient pain relief for up to 48 hours after treatment in some patients with migraine with aura...

Portable Device May Relieve Migraine Pain
Source: MedicineNet Depression Specialty [2010.03.04]
Title: Portable Device May Relieve Migraine Pain
Category: Health News
Created: 3/4/2010 11:05:00 AM
Last Editorial Review: 3/4/2010 11:05:10 AM

Compared To Episodic Migraineurs, Chronic Migraineurs Are Sicker, Poorer And More Depressed
Source: Headache / Migraine News From Medical News Today [2010.02.18]
Research published ahead of print in the Journal of Neurology Neurosurgery and Psychiatry reports that chronic migraine sufferers tend to be in poorer general health, less wealthy, and more depressed than those with episodic migraine. Episodic migraine is a severe headache happening up to 14 days of the month. Chronic migraine is headache happening 15 or more days of the month...

Chronic Migraines Take a Greater Toll
Source: MedicineNet Chronic Pain Specialty [2010.02.18]
Title: Chronic Migraines Take a Greater Toll
Category: Health News
Created: 2/18/2010 8:10:00 AM
Last Editorial Review: 2/18/2010

Migraine More Common In Women With MS
Source: Headache / Migraine News From Medical News Today [2010.02.17]
Migraine is seen more frequently in women with multiple sclerosis (MS) than those without, according to a study released today that will be presented at the American Academy of Neurology's 62nd Annual Meeting in Toronto April 10 to April 17, 2010...

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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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