A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
NCT04530110
Brain Diseases, Central Nervous System Diseases
Aurora, Colorado, United States
View Trial DetailsNCT Number: NCT00725140
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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Notify Me18 year–65 year
All sexes
Observational
28 GPs across France, Diverse, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Time frame: 2 h from intake
Time frame: 24 h
Time frame: 24 h
Time frame: 24 h
Time frame: 24 h
Time frame: Basal - 2h - 24h
Time frame: 24 h
Time frame: 24 h
Time frame: Basal - After each attack
Time frame: From recruitment to study end or AE resolution
Time frame: 2 months
Almirall, S.A.
Industry
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
Acronym: START
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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