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NCT Number: NCT04616326

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Migraine Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanos Clinic - Nordjylland, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
  • Known hypersensitivity monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
  • Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
  • 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).
  • 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.

Treatment and study plan

Galcanezumab

Drug

Administered SQ

Other names: LY2951742

Placebo

Drug

Administered SQ

Primary outcomes

  1. Change from Baseline in the Number of Monthly Migraine Headache Days

    Time frame: Baseline, 3 Months

    Change from Baseline in the Number of Monthly Migraine Headache Days

Secondary outcomes

  1. Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

    Time frame: 3 Months

    Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

  2. 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 Nausea and/or Vomiting

  3. 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 Headache Days with Photophobia and Phonophobia

  4. 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 Headaches with Prodromal Symptoms

  5. Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken

    Time frame: Baseline, 3 Months

    Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken

  6. Patient Global Impression-Improvement (PGI-I) Rating

    Time frame: Month 1 to Month 3

    PGI-I Rating

  7. Change from Baseline in the Severity of Remaining Migraine Headaches per Month

    Time frame: Baseline, 3 Months

    Change from Baseline in the Severity of Remaining Migraine Headaches per Month

  8. Change from Baseline in the Number of Monthly Headache Days

    Time frame: Baseline, 3 Months

    Change from Baseline in the Number of Monthly Headache Days

  9. Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score

    Time frame: Baseline, 3 Months

    Change from Baseline on the PedsQL Total Score

  10. Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score

    Time frame: Baseline, 3 Months

    Change from Baseline on the PedMIDAS Total Score

  11. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: Baseline through 3 Months

    Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score

  12. Pharmacokinetics (PK): Serum Concentration of Galcanezumab

    Time frame: Baseline through 3 Months

    PK: Serum Concentration of Galcanezumab

  13. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

    Time frame: Baseline through 3 Months

    Plasma Concentration of CGRP

  14. Percentage of Participants Developing Anti-Drug Antibodies

    Time frame: Baseline through 3 Months

    Percentage of Participants Developing Anti-Drug Antibodies

  15. Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase

    Time frame: 16 Months

    Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study

Acronym: REBUILD-2

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Nov 4, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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