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Study Summary
This trial will study how well erenumab works to improve satisfaction with migraine medication.
- Migraine
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 4 trial • 701 Patients • NCT04084314Trial Design
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- You have a history of drug or alcohol problems.You have ongoing chronic pain conditions like fibromyalgia or chronic pelvic pain.You have any other important health problems or conditions that could affect your participation in the study.You have been experiencing migraines for at least a year before the screening.You have at least 4 days of migraines each month for the past 3 months before the screening.You have a history of cluster headaches or hemiplegic migraines.You cannot tell if your headache is a migraine or a different type of headache.You have tried and did not respond to more than three different types of medication for preventing migraines.You have told your doctor that your current treatment is not working well for you or that you cannot tolerate it.
- Group 1: Erenumab
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still opportunities for individuals to partake in this research project?
"Per the information present on clinicaltrials.gov, this medical trial is recruiting patients and was originally posted June 11th 2021 with recent updates made November 16th 2022."
What is the aggregate number of individuals participating in this trial?
"Indeed, the trial is currently recruiting. According to clinicaltrials.gov's records, the study was initially unveiled on June 11th 2021 and its details were most recently modified on November 16th 2022. The research team aim to enrol 322 patients from 42 distinct medical sites."
Has the regulatory agency given its stamp of approval to Erenumab?
"As Erenumab is currently being administered in a Phase 4 trial, Power has assessed its safety as 3 out of 3 on their scale."
Does the current protocol of this clinical trial encompass individuals over eighty years old?
"The age restrictions for this trial are quite broad; the minimum permissible age is 18 and the maximum allowable age is 99."
To what extent have researchers explored the benefits of Erenumab?
"At present, there are 18 research initiatives being conducted to explore the effects of Erenumab. Three of these projects have progressed into Phase 3 trials and 549 sites across America are participating in this medical endeavour. The bulk of participants come from Rochester, Minnesota."
Is this medical trial the inaugural of its kind?
"Currently, there are 18 live trials of Erenumab being conducted across 32 countries and 179 cities. The drug's initial trial was sponsored by Amgen in 2019; the Phase 3 approval process included 456 patients before coming to a close. Over the past two years, 26 additional studies have been finalized."
Is there any way I can participate in this research program?
"This medical trial has a set of criteria that need to be fulfilled by prospective participants, including having migraine and being within the age range from 18-99. 322 individuals will have the opportunity to join the study."
How many venues is this analysis being conducted in?
"Thus far, 42 patients have been enrolled in this clinical trial. These participants are located at New Age Medical Research Corporation (Miami), Nuvance Health Neurosciences Institute (Poughkeepsie) and Albuquerque Clinical Trials Inc (Albuquerque). Other sites also participate."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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