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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
Must not have
History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine).
Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights
Pivotal 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.
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).
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with a specific type of severe headache.
Select...
I have a history of brain tumors or specific brain malformations.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in the Number of Monthly Migraine Headache Days
Secondary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~6750

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,677 Previous Clinical Trials
3,465,331 Total Patients Enrolled
27 Trials studying Migraine
10,521 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,824 Total Patients Enrolled
21 Trials studying Migraine
7,648 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
~33 spots leftby Jul 2025
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