A Phase 3 interventional study of Galcanezumab and Placebo in Episodic Migraine, sponsored by Eli Lilly and Company. Active, not recruiting at 73 sites in 10 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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Among 12 studies testing galcanezumab in Headache — none open to participants now, 2 under way, 2 of them phase 3. galcanezumab · Headache.
Among the 12 studies testing galcanezumab in Headache, this one is the 4th largest by enrollment, is one of 2 that started in 2018, is one of 9 in phase 3, and was the 9th registered.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
Browse Headache studies →None of the 12 studies testing galcanezumab in Headache is open now. The open studies under Headache, anywhere →
galcanezumab: first FDA approval 2018 (EMGALITY), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 83 Headache studies recruiting now, 30 (36%) set no upper age limit and 44 (53%) stop at 75 or younger; 10 take children under 18; 14 take healthy volunteers.
This study: 6 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2018.
This study's enrollment of 533 is above the median of 65 across 560 interventional studies indexed under Headache.
Median enrollment 386 across the 12 interventional studies. Of the 10 that completed or were terminated, 10 (100%) have results posted.
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12 of 12 have an industry lead sponsor. The 1 most frequent:
Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
15 studies in Headache by Eli Lilly and Company: none open now, 2 under way, 2 of them phase 3. Of 13 finished, 13 (100%) have results posted.
Among the 15 studies in Headache by Eli Lilly and Company, this one is the 5th largest by enrollment, is one of 2 that started in 2018, is one of 10 in phase 3, and was the 11th registered.
Eli Lilly and Company’s Headache studies by the year they started, since 2008.
None of the studies under way reaches primary completion within a year.
Among the 12 studies testing galcanezumab in Headache, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Eli Lilly and Company’s 15 in Headache:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. 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 has two parts which enroll separately from each other such that participants may choose to participate in either but not both: the main study and a study addendum.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Percentage of participants with reduction from baseline ≥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 Migraine Headache Days on which Acute Headache Medication is Taken
Change from baseline in the number of 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, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Mar 2018 to primary completion in Nov 2025, 92 months.
Of 21 industry-sponsored phase 3 interventional studies under Headache, half reached primary completion within 17 months of starting (the median); a quarter within 13 and three quarters within 31. This study's 92 months is above that.
Counting every sponsor, half of 30 studies reached it within 18 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Galcanezumab