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Galcanezumab for Pediatric Migraine (REBUILD-1 Trial)
REBUILD-1 Trial Summary
This trial is testing if galcanezumab is better than placebo at reducing the number of monthly migraine days in children and teens.
REBUILD-1 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 2021 Phase 4 trial • 65 Patients • NCT04294147REBUILD-1 Trial Design
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Who is running the clinical trial?
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- I haven't had a major head or neck injury in the last 6 months that worsened my headaches.I have a history of brain tumors or specific brain malformations.I have used or been exposed to CGRP antibodies or receptor antibodies.I am not currently on, nor planning to take, any therapeutic antibodies like adalimumab.I have been diagnosed with migraines for at least 6 months.I have been diagnosed with a specific type of severe headache.I am allergic to some specific protein treatments or their ingredients.
- Group 1: Galcanezumab
- Group 2: 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
What other Galcanezumab research studies have been completed?
"Galcanezumab was first researched in 2018 by Bio Behavioral Health. Out of the 18,284 completed clinical trials, there are 6 active studies. The majority of these ongoing investigations are based in Long Beach, California."
Has Galcanezumab been cleared by the FDA?
"Galcanezumab was given a 3 because Phase 3 trials have shown some efficacy and there is extensive safety data available."
Is this clinical trial investigating something new?
"Galcanezumab is being studied in 6 different ongoing trials, with a total of 325 participants spread out over 11 countries and 141 cities. The first study was sponsored by Eli Lilly and Company back in 2018, and it completed Phase 3 drug approval that year. As of now, 18284 similar studies have been conducted."
Is this medical study recruiting young adults?
"This particular clinical trial is enrolling patients that are under the age of 17 but older than 6 years old."
Out of the total pool of applicants, how many people will be chosen for this research project?
"The trial requires a total of 325 participants that meet the clinical study's inclusion criteria. The manufacturer, Eli Lilly and Company, will be managing the research from various sites including Long Beach Memorial Medical Center in Long Beach, California and Meridian Clinical Research, LLC in Savannah, Georgia."
Are there multiple sites where I can participate in this research?
"This trial is taking place at 52 different research centres, some of which are Long Beach Memorial Medical Center, Meridian Clinical Research LLC and Velocity Clinical Research."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
Typically responds via
Most responsive sites:
- Clinical Research Center of Florida: < 24 hours
Average response time
- < 1 Day
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