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Monoclonal Antibodies
Galcanezumab for Pediatric Migraine (REBUILD-1 Trial)
Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights
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.
Who is the study for?
This trial is for kids and teens aged 6 to 17 with episodic migraines, as defined by IHS ICHD-3 guidelines. They must have had migraines for at least six months before screening. Those who've used certain therapeutic antibodies in the past year or are allergic to monoclonal antibodies can't join.Check my eligibility
What is being tested?
The study tests if Galcanezumab (LY2951742) is better than a placebo at preventing migraine headaches over three months. Participants will be randomly assigned to receive either Galcanezumab or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects of Galcanezumab may include reactions where the injection was given, allergy-like symptoms, and other potential immune responses due to its nature as a monoclonal antibody.
REBUILD-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in the Number of Monthly Migraine Headache Days
Secondary outcome measures
Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken
Change from Baseline in the Number of Monthly Headache Days
Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
+12 moreSide effects data
From 2021 Phase 4 trial • 65 Patients • NCT0429414716%
Constipation
6%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
140 mg Erenumab SC
240 mg Galcanezumab SC
REBUILD-1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GalcanezumabExperimental Treatment1 Intervention
Galcanezumab administered by SQ injection.
Participants may be eligible for optional open-label extension at the end of the double-blind period.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered by SQ injection.
Participants may be eligible for optional open-label extension at the end of the double-blind period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galcanezumab
2015
Completed Phase 4
~6760
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,619 Previous Clinical Trials
3,206,274 Total Patients Enrolled
27 Trials studying Migraine
10,528 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,420 Total Patients Enrolled
21 Trials studying Migraine
7,655 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Galcanezumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Migraine Patient Testimony for trial: Trial Name: NCT03432286 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Florida
New Jersey
How old are they?
18 - 65
What site did they apply to?
Jackson Memorial Hospital
Clinical Research Center of Florida
Clinical Research Center of Nevada
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I suffer from severe migraine and nothing seems to work I have chronic migraines several days a week which makes it hard to function in life for me I just want to find something that will work for me.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Clinical Research Center of Florida: < 24 hours
Average response time
- < 1 Day
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