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| Tracking Information | |||||
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| First Received Date ICMJE | July 29, 2008 | ||||
| Last Updated Date | October 7, 2009 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain Free [ Time Frame: 2 h from intake ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00725140 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Standardized sTudy With Almotriptan in eaRly Treatment of Migraine | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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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| Detailed Description | 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:
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Migraine | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 501 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France, Italy, Spain | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00725140 | ||||
| Responsible Party | Carlos Vila, International Medical Advisor, GM&MA, Laboratorios Almirall S.A., Laboratorios Almirall, S.A. | ||||
| Study ID Numbers ICMJE | M/31416/51, EudraCT: 2007-003392-39, Spanish AEM: ALM-ALM-2008-01 | ||||
| Study Sponsor ICMJE | Almirall S.A. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Almirall S.A. | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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