AXERT SUMMARY
AXERT® (almotriptan malate) Tablets contain almotriptan malate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.
Acute Treatment of Migraine Attacks
Adults
AXERT® (almotriptan malate) is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.
Adolescents Age 12 to 17 Years
AXERT® is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).
Important Limitations
AXERT® should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with AXERT®, the diagnosis of migraine should be reconsidered before AXERT® is administered to treat any subsequent attacks.
In adolescents age 12 to 17 years, efficacy of AXERT® on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. 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 HIGHLIGHTSMedia Articles Related to Axert (Almotriptan)
Pictures of Famous People Coping With Migraines Source: MedicineNet Headache Specialty [2017.09.08] Title: Pictures of Famous People Coping With Migraines Category: Slideshows Created: 11/5/2012 12:00:00 AM Last Editorial Review: 9/8/2017 12:00:00 AM
Many Migraine Sufferers Given Unecessary Opioids, Study Finds Source: MedicineNet Headache Specialty [2017.08.28] Title: Many Migraine Sufferers Given Unecessary Opioids, Study Finds Category: Health News Created: 8/25/2017 12:00:00 AM Last Editorial Review: 8/28/2017 12:00:00 AM
Migraine vs. Headache: Differences and Similarities Source: MedicineNet Analgesics, Antipyretics Specialty [2017.06.26] Title: Migraine vs. Headache: Differences and Similarities Category: Diseases and Conditions Created: 6/21/2017 12:00:00 AM Last Editorial Review: 6/26/2017 12:00:00 AM
Migraine Source: MedicineNet amitriptyline Specialty [2017.05.22] Title: Migraine Category: Symptoms and Signs Created: 2/27/2015 12:00:00 AM Last Editorial Review: 5/22/2017 12:00:00 AM
Migraine Headache Source: MedicineNet Antiphospholipid Syndrome Specialty [2017.03.13] Title: Migraine Headache Category: Diseases and Conditions Created: 12/31/1997 12:00:00 AM Last Editorial Review: 3/13/2017 12:00:00 AM
Published Studies Related to Axert (Almotriptan)
The impact of allodynia on the efficacy of almotriptan when given early in migraine: data from the "act when mild" study. [2011.12] ABSTRACT The objective of this study was to evaluate the impact of allodynia on treatment outcomes in the patients with acute migraine treated in the "Act when Mild" (AwM) study. AwM, a randomized placebo-controlled trial, studied almotriptan 12.5 mg in the early treatment (within 1 hr) of acute migraine when the pain was still mild, and investigated clinical outcomes in the presence or absence of allodynia, which was prospectively recorded using patient questionnaires.
A double-blind, randomized, multicenter, Italian study of frovatriptan versus almotriptan for the acute treatment of migraine. [2011.06] The objective of this study was to evaluate patients' satisfaction with acute treatment of migraine with frovatriptan or almotriptan by preference questionnaire. One hundred and thirty three subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or almotriptan 12.5 mg, treating 1-3 attacks...
Almotriptan 12.5 mg in menstrually related migraine: a randomized, double-blind, placebo-controlled study. [2011.01] BACKGROUND: Menstrually related migraine (MRM) affects more than half of female migraineurs. Because such migraines are often predictable, they provide a suitable target for treatment in the mild pain phase. The present study was designed to provide prospective data on the efficacy of almotriptan for treatment of MRM... CONCLUSION: Almotriptan was significantly more effective than placebo in women with MRM attacks, with consistent efficacy in longer-term follow-up.
Evolution of migraine-associated symptoms in menstrually related migraine following symptomatic treatment with almotriptan. [2010.06] In addition to headache, migraine is characterized by a series of symptoms that negatively affects the quality of life of patients. Generally, these are represented by nausea, vomiting, photophobia, phonophobia and osmophobia, with a cumulative percentage of the onset in about 90% of the patients.Data suggest that almotriptan shows excellent efficacy on MAS in comparison to the placebo, with a significant reduction in the percentages of suffering patients over a 2-h period of time.
Efficacy of almotriptan in early intervention for treatment of acute migraine in a primary care setting: the START study. [2010.06] AIMS: The benefits of taking almotriptan early for acute migraine when pain is mild have clearly been demonstrated in the neurology setting. The aim of this study was to determine whether similar benefits with early intervention of almotriptan can be achieved in everyday general practice, where most migraineurs are managed... CONCLUSIONS: In the primary care setting, early intervention with almotriptan for treatment of migraine provides significant clinical benefits compared with delaying treatment and/or waiting until pain intensity has progressed beyond mild.
Clinical Trials Related to Axert (Almotriptan)
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches [Completed]
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.
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 3 Dosage Strengths of Almotriptan 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.
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.
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