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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
Must not have
History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
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 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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had a major head or neck injury in the last 6 months that worsened my headaches.
Select...
I have a history of brain tumors or specific brain malformations.
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I have used or been exposed to CGRP antibodies or receptor antibodies.
Select...
I have been diagnosed with a specific type of severe headache.
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I am allergic to some specific protein treatments or their ingredients.

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 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 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
2,680 Previous Clinical Trials
3,466,059 Total Patients Enrolled
27 Trials studying Migraine
10,521 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,516 Total Patients Enrolled
21 Trials studying Migraine
7,648 Patients Enrolled for Migraine

Media Library

Galcanezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03432286 — Phase 3
Migraine Research Study Groups: Galcanezumab, Placebo
Migraine Clinical Trial 2023: Galcanezumab Highlights & Side Effects. Trial Name: NCT03432286 — Phase 3
Galcanezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03432286 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT03432286 — Phase 3
~36 spots leftby Nov 2025
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