Standardized sTudy With Almotriptan in eaRly Treatment of Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary Objective: 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. Secondary Objectives: Influence of an educational intervention on the early intake of the treatment Influence of medication history or concomitant medication on treatment results Influence of migraine triggers on treatment results Influence of stress on treatment results Tolerability profile validation Patients' satisfaction Reasons for delaying migraine treatment intake

Official Title
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Standardized sTudy With Almotriptan in eaRly Treatment of Migraine, START. An International, Open-label, Single Arm, Effectiveness and Safety Study of Almotriptan in Primary Care Setting

Conditions
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Migraine

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of a confirmed diagnosis of migraine that meets the IHS diagnosis criteria of migraine with or without aura for at least one year. Patients with a history of migraine headaches progressing from mild to at least moderate pain intensity if untreated on a scale of no pain (0), mild (1), moderate (2), or severe (3) within the past year. Migraine headache frequency of 2 to 6 per month for the past 3 months. Male or female aged 18 to 65 years. Able to differentiate a migraine headache from an interval (e.g., tension-type) headache. 8.Female patients of childbearing potential must not suspect to be pregnant and have an effective method of birth control for at least 30 days prior to study entry and throughout the study. 11.After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study. 12.Patients must either use Almotriptan for their migraine acute attacks treatment or prove through the ANAES scale in the basal visit that a change in their treatment approach is required. Exclusion Criteria: Patients, who in the opinion of the investigator, should not be enrolled in the study because of the precautions, warnings or contraindications sections of the Almotriptan Summary of Product Characteristics. Patients who have had 15 or more headache days per month in the previous 6 months (chronic daily headache), or patients having a migraine headache frequency of more than 6 per month for the past 3 months. Patients with onset of migraine after age 50. Patients who routinely experience any other type of headache that would confound discrimination from a migraine. Patients who have exclusively migraine aura without headache. Patients who typically experience vomiting with their headaches. Patients with hemiplegic or basilar type migraines. Patients who typically have headaches that occur predominantly upon awakening in the morning. Patients who have previously discontinued Almotriptan therapy due to an adverse event or lack of efficacy. 11.Patients taking any of the prohibited concomitant medications listed in Section 10.3.1 of the protocol. 12.Patients who have used any of the following medications within 7 days of study entry and during the trial: sustained release opioids and/or semi-synthetic or long acting opioids. 16.Women who are pregnant or lactating. 18.Patients who have received an investigational drug or used an investigational device within 30 days of study entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Free |  | 2 h from intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Pain Free |  | 24 h | 
| SNAE (Sustained pain free and No Adverse Events) |  | 24 h | 
| Relapse |  | 24 h | 
| Second tablet / rescue medication use |  | 24 h | 
| Associated symptoms presence evolution: Nausea, Vomiting, Photophobia, Phonophobia. |  | Basal - 2h - 24h | 
| Migraine attack duration |  | 24 h | 
| Time loss (functional disability) |  | 24 h | 
| Patients' satisfaction: |  | Basal - After each attack | 
| Adverse Events |  | From recruitment to study end or AE resolution | 
| Consistency of response to treatment between attacks (2 h PF in 2/3 attacks) |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Early intervention, Primary Care, Almotriptan