A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine (REBUILD-1)
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ClinicalTrials.gov Identifier: NCT03432286 |
Recruitment Status :
Recruiting
First Posted : February 14, 2018
Last Update Posted : December 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Episodic Migraine | Drug: Galcanezumab Drug: Placebo | Phase 3 |
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.
- The main 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.
- The study addendum is a stand-alone study of galcanezumab pharmacokinetics and safety in a group of participants separate from those in the main study. The study addendum includes a 5-month evaluation period after a single injection of galcanezumab, followed by a 9-month open-label extension.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 325 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study |
Actual Study Start Date : | March 14, 2018 |
Estimated Primary Completion Date : | December 30, 2022 |
Estimated Study Completion Date : | January 9, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Galcanezumab
Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period. |
Drug: Galcanezumab
Administered SQ
Other Name: LY2951742 |
Placebo Comparator: Placebo
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 |
- 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
- Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days [ Time Frame: 3 Months ]Percentage of participants with reduction from baseline ≥50%, ≥75% and 100% in monthly migraine headache days
- 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
- 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
- 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
- Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken [ Time Frame: Baseline, 3 Months ]Change from baseline in the number of migraine headache days on which acute headache medication is taken
- Patient Global Impression-Improvement (PGI-I) Rating [ Time Frame: Month 1 to Month 3 ]PGI-I rating
- 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
- 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
- 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
- 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
- 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
- Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: Baseline through 3 Months ]PK: Serum concentration of galcanezumab
- Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through 3 Months ]Plasma concentration of CGRP
- Percentage of Participants Developing Anti-Drug Antibodies [ Time Frame: Baseline through 3 Months ]Percentage of participants developing anti-drug antibodies
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 [2018]), with a history of migraine headaches of at least 6 months prior to screening.
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.
- Known hypersensitivity to 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432286
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | Clinicaltrials.gov@lilly.com |

Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03432286 |
Other Study ID Numbers: |
16352 I5Q-MC-CGAS ( Other Identifier: Eli Lilly and Company ) 2017-004351-23 ( EudraCT Number ) |
First Posted: | February 14, 2018 Key Record Dates |
Last Update Posted: | December 28, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
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. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
pediatric children prevention |
prophylaxis headache pediatric migraine |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |