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Lasmiditan for Pediatric Migraine (PIONEER-PEDS1 Trial)
PIONEER-PEDS1 Trial Summary
This trial will test the safety and effectiveness of lasmiditan in treating migraines in children aged 6-17. Up to 4 visits over 20 weeks may be required.
PIONEER-PEDS1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:PIONEER-PEDS1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 2171 Patients • NCT02565186PIONEER-PEDS1 Trial Design
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Who is running the clinical trial?
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- I was diagnosed with migraines over 6 months ago.I weigh at least 15 kilograms.My child weighs at least 33 pounds.My child can swallow a tablet.My child experiences 2-8 migraines monthly.
- Group 1: Lasmiditan Low Dose
- Group 2: Lasmiditan High Dose
- Group 3: Lasmiditan Mid Dose
- Group 4: 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
When will Lasmiditan be available for public use?
"Lasmiditan has been given a safety score of 3 by our analysts at Power. This is because Lasmiditan is in a Phase 3 clinical trial, meaning that there is some evidence of efficacy as well as multiple rounds of data supporting safety."
If somebody is under 40 years old, can they participate in this clinical trial?
"This study is enrolling participants that are aged 6-17 years old."
What does the current research tell us about Lasmiditan?
"There are currently 2 Phase 3 trials underway investigating the efficacy of lasmiditan. However, this is not the full extent of research being conducted as there are 500 different clinical trial sites operating around the world."
How many willing participants are being recruited for this experiment?
"In order to carry out this study, 1633 participants that meet the pre-specified inclusion criteria are required. These potential patients can be recruited from various locations, such as AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research in Hoffman Estates, Illinois and University Hospital Cleveland Medical Center in Cleveland, Ohio."
Are there a lot of these research programs taking place in city?
"There are 4 main enrolling locations for this trial, which are AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research in Hoffman Estates, Illinois, University Hospital Cleveland Medical Center in Cleveland, Ohio, and New England Institute for Clinical Research in Stamford, Connecticut. In addition, there are 100 other sites where this trial is taking place."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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