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Monoclonal Antibodies

Galcanezumab for Migraine (REBUILD-2 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
Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights

REBUILD-2 Trial Summary

This trial is testing if galcanezumab is better than placebo at reducing the number of monthly migraine days in adolescents 12-17 years old.

Who is the study for?
This trial is for young people aged 12 to 17 with chronic migraine, meaning they've had headaches on at least 15 days per month for the last three months, with migraine features on at least eight of those days. They can't join if they have brain tumors or malformations, are taking certain antibodies (except if used more than a year ago), have specific headache diagnoses other than chronic migraine, are allergic to monoclonal antibodies or galcanezumab's ingredients, or have used CGRP-targeting drugs recently.Check my eligibility
What is being tested?
The study tests whether Galcanezumab is better than a placebo in reducing the number of monthly migraine days over three months in teens. Participants will be randomly assigned to receive either Galcanezumab or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
Possible side effects include reactions where the drug is injected, such as pain or swelling; allergic reactions; and constipation. There may also be other side effects not yet known due to limited use in this age group.

REBUILD-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic migraines, with headaches most days each month.

REBUILD-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 months for reporting.

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 Monthly Headache Days
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
+12 more

Side effects data

From 2021 Phase 4 trial • 65 Patients • NCT04294147
16%
Constipation
6%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
140 mg Erenumab SC
240 mg Galcanezumab SC

REBUILD-2 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
2,620 Previous Clinical Trials
3,216,299 Total Patients Enrolled
27 Trials studying Migraine
10,528 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,445 Total Patients Enrolled
21 Trials studying Migraine
7,655 Patients Enrolled for Migraine

Media Library

Galcanezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04616326 — Phase 3
Migraine Research Study Groups: Galcanezumab, Placebo
Migraine Clinical Trial 2023: Galcanezumab Highlights & Side Effects. Trial Name: NCT04616326 — Phase 3
Galcanezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04616326 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this test phase of the treatment?

"That is accurate. According to the information available on clinicaltrials.gov, this research is currently seeking patients. The listing for this trial was first posted on November 25th, 2020 and was updated most recently on October 17th, 2022. The study needs to enroll 300 participants from 51 different sites."

Answered by AI

Are there vacant slots in this experiment for new participants?

"That is accurate. According to the clinicaltrials.gov website, this trial was originally posted on November 25th 2020. The 300 patients needed for the trial are being recruited from 51 locations."

Answered by AI

Are people of all ages being accepted for this clinical trial, or are only adults over the age of 50 able to participate?

"The age criteria for participants in this study is between 12 and 17 years old."

Answered by AI

In how many different research facilities is this trial being run today?

"Currently, there are 51 patients enrolled in this clinical trial. In addition to Synergy Clinical Research, LLC in Pensacola, Minneapolis Clinic of Neurology in Burnsville, and Velocity Clinical Research-Providence in Warwick, there are 51 other locations participating."

Answered by AI

Does Galcanezumab carry any serious risks for patients?

"Galcanezumab has been deemed safe by our team at Power, who rated it a 3. This is because Phase 3 trials have provided some data to support efficacy as well as multiple rounds of data supporting safety."

Answered by AI

What are the inclusionary criteria for this particular clinical trial?

"This migraine clinical trial is currently looking for around 300 adolescent patients that suffer from chronic migraines. To be eligible, participants must be between 12 and 17 years old."

Answered by AI

To the best of your knowledge, is this the first time this type of experiment has been conducted?

"Since 2018, Galcanezumab has been the subject of medical research. In 2018, the first clinical trial was completed. This initial study was conducted by Eli Lilly and Company. After the first Phase 3 drug approval in 2018, which required 325 patients, there are now 6 active studies being conducted in 141 cities and 11 countries."

Answered by AI

Are there precedents for the use of Galcanezumab in a clinical capacity?

"There are six different ongoing studies researching Galcanezumab. Two of these studies are currently in Phase 3. Many of the clinical trials related to Galcanezumab are based in Brookline, Massachusetts, but there are a total of 330 locations running trials for Galcanezumab."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Pharmasite Research, Inc.
Rare Disease Research, LLC
Recent research and studies
clinicaltrials.govStudy
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
2020. "A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04616326.
All > Prevention > Migraine
~80 spots leftby Jul 2025
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