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

Episodic Migraine Clinical Trial

— REBUILD-1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03432286
• Other study ID #: 16352
• Secondary ID: I5Q-MC-CGAS2017-
• Status: Recruiting
• Phase: Phase 3
• Start date: March 14, 2018
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: Clinicaltrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Galcanezumab
Administered SQ
• Placebo
Administered SQ

Locations

Country	Name	City	State
Denmark	Sanos Clinic - Nordjylland	Aalborg	Nordjylland
Denmark	Herlev and Gentofte Hospital	Copenhagen	Hovedstaden
Germany	Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Sp -T	Essen	Nordrhein-Westfalen
India	Mangala Hospital & Mangala Kidney Foundation	Mangalore	Karnataka
India	All India Institute of Medical Sciences (AIIMS) - Nagpur	Nagpur	Maharashtra
India	Central India Cardiology and Research Institute	Nagpur	Maharashtra
India	Lillestol Research	Nagpur	Maharashtra
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	G.B. Pant Institute of Postgraduate Medical Education & Research	New Delhi	Delhi
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Medipoint Hospitals Pvt. Ltd.	Pune	Maharashtra
Italy	IRCCS Istituto Neurologico Carlo Besta	Milano	Lombardia
Italy	Universita degli Studi della Campania Luigi Vanvitelli	Napoli	Campania
Italy	Ospedale Pediatrico Bambino Gesù	Roma
Italy	Policlinico Umberto I	Roma	Lazio
Japan	Konan Hospital	Kobe	Hyogo
Japan	Umenotsuji Clinic	Kochi
Japan	Tatsuoka Neurology Clinic	Kyoto
Japan	Yamaguchi Clinic	Nishinomiya	Hyogo
Japan	Tominaga Hospital	Osaka
Japan	Sendai Headache and Neurology Clinic	Sendai	Miyagi
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Mexico	Centro de Investigacion Medica Aguascalientes	Aguascalientes
Mexico	Unidad de Investigación en Salud	Chihuahua
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	PanAmerican Clinical Research - Guadalajara	Guadalajara	Jalisco
Mexico	Hospital Infantil de Mexico Federico Gomez	Mexico City
Mexico	Clinica De Enfermedades Cronicas y Procedimientos Especiales	Morelia	Michoacan
Netherlands	Isala, locatie Zwolle	Zwolle	Overijssel
Puerto Rico	Dr. Samuel Sanchez PSC	Caguas
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
Puerto Rico	Barbara Diaz-Hernandez MD Research, Inc.	San Juan
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Clinico de Valencia	Valencia	Valenciana, Comunitat
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
United States	Dent Neurologic Institute	Amherst	New York
United States	Medical Research Partners	Ammon	Idaho
United States	Rare Disease Research, LLC	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Northwest Clinical Trials	Boise	Idaho
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Minneapolis Clinic of Neurology - Burnsville Office	Burnsville	Minnesota
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	Northwell Health	Great Neck	New York
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	St. Alexius Medical Center	Hoffman Estates	Illinois
United States	Pain and Headache Centers of Texas	Houston	Texas
United States	Rehabilitation & Neurological Services	Huntsville	Alabama
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Jacksonville	Florida
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Miller Children's & Women's Hospital Long Beach	Long Beach	California
United States	Velocity Clinical Research, Boise	Meridian	Idaho
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	Ezy Medical Research	Miami	Florida
United States	University of Miami Don Suffer Clinical Research Building	Miami	Florida
United States	Cohen Children's Northwell Health Physician Partners - Pediatric Neurology	New Hyde Park	New York
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	Orange County Research Institute	Ontario	California
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	College Park Specialty Center	Overland Park	Kansas
United States	Avanza Medical Research Center	Pensacola	Florida
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Xenoscience	Phoenix	Arizona
United States	Office 18	Pittsburgh	Pennsylvania
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Providence Health & Services	Portland	Oregon
United States	Velocity Clinical Research at Raleigh Neurology	Raleigh	North Carolina
United States	Wr-McCr, Llc	San Diego	California
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Seattle Children's Hospital	Seattle	Washington
United States	ForCare Clinical Research	Tampa	Florida
United States	USF Health	Tampa	Florida
United States	Center for Neurosciences	Tucson	Arizona
United States	MedVadis Research Corporation	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Denmark,  Germany,  India,  Italy,  Japan,  Mexico,  Netherlands,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Number of Monthly Migraine Headache Days	Change from baseline in the number of monthly migraine headache days	Baseline, 3 Months
Secondary	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	3 Months
Secondary	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	Baseline, 3 Months
Secondary	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	Baseline, 3 Months
Secondary	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	Baseline, 3 Months
Secondary	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	Baseline, 3 Months
Secondary	Patient Global Impression-Improvement (PGI-I) Rating	PGI-I rating	Month 1 to Month 3
Secondary	Change from Baseline in the Severity of Remaining Migraine Headaches per Month	Change from baseline in the severity of remaining migraine headaches per month	Baseline, 3 Months
Secondary	Change from Baseline in the Number of Monthly Headache Days	Change from baseline in the number of monthly headache days	Baseline, 3 Months
Secondary	Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score	Change from Baseline on the PedsQL total score	Baseline, 3 Months
Secondary	Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score	Change from baseline on the PedMIDAS total score	Baseline, 3 Months
Secondary	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	Baseline through 3 Months
Secondary	Pharmacokinetics (PK): Serum Concentration of Galcanezumab	PK: Serum concentration of galcanezumab	Baseline through 3 Months
Secondary	Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)	Plasma concentration of CGRP	Baseline through 3 Months
Secondary	Percentage of Participants Developing Anti-Drug Antibodies	Percentage of participants developing anti-drug antibodies	Baseline through 3 Months
Secondary	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	16 Months

External Links

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