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| Sponsor: | Almirall, S.A. |
|---|---|
| Information provided by: | Almirall, S.A. |
| ClinicalTrials.gov Identifier: | NCT00725140 |
Purpose
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.
| Condition |
|---|
|
Migraine |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
| Enrollment: | 501 |
| Study Start Date: | June 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Single |
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:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Following SPC conditions and study requirements, male or female of 18 to 65 years old with a minimum of one year of migraine history (International Headache Society criteria, see criteria attached in the protocol Annex 1) of moderate or severe intensity and with a frequency of 2 to 6 attacks per month for the past 3 months.
Inclusion Criteria:
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:
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.
Contacts and Locations| France | |
| 28 GPs across France | |
| 28, France | |
| Italy | |
| 26 GPs across Italy | |
| Diverse, Italy | |
| Spain | |
| 26 GP practices across Spain | |
| 26, Spain | |
| Study Chair: | Michel Lanteri-Minet, Dr | Pain Evaluation and Treatment Department, Hopital Pasteur, Nice, France |
More Information
| Responsible Party: | Carlos Vila, International Medical Advisor, GM&MA, Laboratorios Almirall S.A., Laboratorios Almirall, S.A. |
| ClinicalTrials.gov Identifier: | NCT00725140 History of Changes |
| Other Study ID Numbers: | M/31416/51, EudraCT: 2007-003392-39, Spanish AEM: ALM-ALM-2008-01 |
| Study First Received: | July 29, 2008 |
| Last Updated: | October 7, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines; France: Ministry of Health; Italy: Ministry of Health |
|
Migraine Early intervention Primary Care Almotriptan |
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Almotriptan |
Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |