A Phase 3 interventional study of Galcanezumab and Placebo in Chronic Migraine, sponsored by Eli Lilly and Company. Active, not recruiting at 88 sites in 11 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
The study includes a 3-month, randomized, double-blind treatment period in which participants receive either galcanezumab or placebo, followed by a 9-month open-label extension in which all participants receive galcanezumab. Enrollment in the European Union may also include participants 6 to 11 years of age.
1,226 studies on the registry are indexed under Headache; 202 are open to participants now.
This study's enrollment of 312 is above the median of 60 across 918 interventional studies indexed under Headache.
Browse Headache studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
Drug: Galcanezumab
Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
Drug: Placebo
Administered SQ
Also known as: LY2951742
Administered SQ
Change from Baseline in the Number of Monthly Migraine Headache Days
Change from Baseline in the Number of Monthly Migraine Headache Days
Time frame: Baseline, 3 Months
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Time frame: 3 Months
Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
Time frame: Baseline, 3 Months
Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
Time frame: Baseline, 3 Months
Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
Time frame: Baseline, 3 Months
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 on Which Acute Headache Medication is Taken
Time frame: Baseline, 3 Months
Patient Global Impression-Improvement (PGI-I) Rating
PGI-I Rating
Time frame: Month 1 to Month 3
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Time frame: Baseline, 3 Months
Change from Baseline in the Number of Monthly Headache Days
Change from Baseline in the Number of Monthly Headache Days
Time frame: Baseline, 3 Months
Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score
Change from Baseline on the PedsQL Total Score
Time frame: Baseline, 3 Months
Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score
Change from Baseline on the PedMIDAS Total Score
Time frame: Baseline, 3 Months
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score
Time frame: Baseline through 3 Months
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
PK: Serum Concentration of Galcanezumab
Time frame: Baseline through 3 Months
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of CGRP
Time frame: Baseline through 3 Months
Percentage of Participants Developing Anti-Drug Antibodies
Percentage of Participants Developing Anti-Drug Antibodies
Time frame: Baseline through 3 Months
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
Time frame: 16 Months
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company