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A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine (REBUILD)

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ClinicalTrials.gov Identifier: NCT03432286
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to determine the safety and efficacy of the study drug galcanezumab in participants 6 to 17 years of age with episodic migraine.

Condition or disease Intervention/treatment Phase
Episodic Migraine Drug: Galcanezumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 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 Study
Estimated Study Start Date : March 31, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 26, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Galcanezumab
Galcanezumab administered by subcutaneous (SQ) injection.
Drug: Galcanezumab
Administered SQ
Other Name: LY2951742

Placebo Comparator: Placebo
Placebo administered by SQ injection.
Drug: Placebo
Administered SQ




Primary Outcome Measures :
  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 Outcome Measures :
  1. Proportion of Participants with Reduction from Baseline ≥50% in Monthly Migraine Headache Days [ Time Frame: 3 Months ]
    Proportion of participants with reduction from baseline ≥50% in monthly migraine headache days

  2. Change from Baseline in the Number of Monthly Headache Days with Nausea and/or Vomiting [ Time Frame: Baseline, 3 Months ]
    Change from baseline in the number of monthly headache days with nausea and/or vomiting

  3. Change from Baseline in the Number of Monthly Headache Days with Photophobia and Phonophobia [ Time Frame: Baseline, 3 Months ]
    Change from baseline in the number of monthly 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 Days on Which Acute Migraine Treatments are Taken per Month [ Time Frame: Baseline, 3 Months ]
    Change from baseline in the number of days on which acute migraine treatments are taken per month

  6. Patient Global Impression-Improvement (PGI-I) Rating [ Time Frame: 3 Months ]
    PGI-I rating

  7. 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

  8. 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

  9. 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

  10. Change from Baseline on the Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) [ Time Frame: Baseline, 3 Months ]
    Change from baseline on the PSMQ-M

  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. Proportion of Participants who Initiate Migraine Prevention Medication [ Time Frame: 16 Months ]
    Proportion of participants who initiate migraine prevention medication



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of migraine as defined by the International Headache Society International Classification of Headache Disorders (IHS ICHD-3) beta guidelines (1.1 or 1.2) (ICHD-3 2013), 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, other than antibodies to calcitonin gene-related peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior to baseline.
  • Known hypersensitivity to multiple drugs, 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 persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine) as defined by IHS ICHD-3 beta.
  • History of any type of headache except for migraine, tension type headache, or medication overuse headache, as defined by IHS ICHD-3 beta, in the 3 months prior to randomization. For example, a history of post-traumatic headache in this 3-month period would not be allowed.
  • History of traumatic head injury, 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.

Information from the National Library of Medicine

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


Contacts
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

Locations
United States, California
Medical Center for Clinical Research Recruiting
San Diego, California, United States, 92108
Contact    619-521-2830      
Principal Investigator: William Koltun         
United States, Florida
Clinical Neuroscience Solutions Inc Not yet recruiting
Jacksonville, Florida, United States, 32256
Contact    904-281-5757      
Principal Investigator: Nandita Jones         
Psychiatric Inst of Florida-Clinical Neuroscience Solutions Recruiting
Orlando, Florida, United States, 32801
Contact    407-425-5100      
Principal Investigator: Linda Harper         
Premiere Research Institute at Palm Beach Neurology Not yet recruiting
West Palm Beach, Florida, United States, 33407
Contact    561-845-0500      
Principal Investigator: Paul Winner         
United States, Georgia
Atlanta Center of Medical Research Not yet recruiting
Atlanta, Georgia, United States, 30331
Contact    404-881-5800      
Principal Investigator: Robert Riesenberg         
United States, Illinois
Alexian Brothers Medical Center Not yet recruiting
Hoffman Estates, Illinois, United States, 60169
Contact    847-593-8553      
Principal Investigator: Hossam AbdelSalam         
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact    919-668-4000      
Principal Investigator: Klaus Werner         
United States, Ohio
Cincinnati Childrens Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact    513-636-4222      
Principal Investigator: Marielle Kabbouche-Samaha         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    215-590-1419      
Principal Investigator: Christina Szperka         
Preferred Primary Care Physicians Recruiting
Pittsburgh, Pennsylvania, United States, 15236
Contact    412-650-6155      
Principal Investigator: Nathan Bennett         
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007-4209
Contact    425-453-0404      
Principal Investigator: Arifulla Khan         
Puerto Rico
Office of Dr. Samuel Sanchez PSC Recruiting
Caguas, Puerto Rico, 00727
Contact    7877463136      
Principal Investigator: Karen Cruz         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03432286     History of Changes
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: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases