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Erenumab for Migraine (OASIS(CM) Trial)
OASIS(CM) Trial Summary
This trial will test if erenumab is effective and safe in preventing migraine in children and adolescents with chronic migraine. The hypothesis is that erenumab will reduce the number of monthly migraine days compared to placebo.
OASIS(CM) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOASIS(CM) Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OASIS(CM) Trial Design
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Who is running the clinical trial?
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- I am a child or teenager who can agree to join the study.I have had continuous migraine pain without any pain-free periods for the last month.I have a stable, mild psychiatric condition and take no more than 1 medication for it.I've tried more than 3 types of migraine prevention medications without success.I have a history of cluster or hemiplegic migraine headaches.You have a history of trying to hurt yourself or others, or you might be at risk of doing so.
- Group 1: Dose Level 1
- Group 2: Dose Level 2
- Group 3: Placebo
- 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
Does this research encompass patients that are elderly?
"This clinical trial is recruiting participants who are aged 6 to 17 years old."
Who would fit the requirements to take part in this clinical trial?
"This trial is looking for 286 participants aged 6-17 who suffer from migraines. The ideal candidate should have a history of migraines (with or without aura) for at least 12 months before screening, according to the IHS Classification ICHD-3. In addition, the candidate should have demonstrated at least 80% compliance with an eDiary over the last 28 days of the baseline period, if more than 28 days in duration. Headache frequency should also be greater than or equal to 15 headache days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days"
Are Canadian medical facilities participating in this trial?
"Patients are being recruited from Josephson Wallack Munshower Neurology in Indianapolis, Indiana, Preferred Primary Care Physicians, Inc in Pittsburgh, Pennsylvania, Childrens Mercy Hospital and Clinics in Kansas City, Missouri, and 24 other locations."
Are there any other similar studies to this one?
"As of now, 18 different international trials for Erenumab Dose 3 are ongoing in 178 cities and 32 countries. The first trial was sponsored by Novartis in 2019. That particular trial reached Phase 3 approval and involved 456 patients. In the two years since the Novartis study, 18252 more trials have been completed."
Are there any other trials that have included Erenumab Dose 3?
"As of right now, there are 18 different clinical trials being conducted for Erenumab Dose 3. Three of those trials are in Phase 3. Even though the majority of the trials for this treatment are based in Scottsdale, Arizona, 547 different locations are running studies."
Is Erenumab Dose 3 safe for human consumption?
"Erenumab Dose 3 is considered safe by our team at Power. This is a Phase 3 trial, which means that there is not only data supporting efficacy, but also multiple rounds of data supporting safety."
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