Clinical trial NCT03432286: A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Episodic Migraine
Keywords: pediatric
children
prevention
prophylaxis
headache
pediatric migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 325
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the Number of Monthly Migraine Headache Days
timeFrame: Baseline, 3 Months
Secondary outcomes:
measure: Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
timeFrame: 3 Months
measure: Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
timeFrame: Baseline, 3 Months
measure: Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
timeFrame: Baseline, 3 Months
measure: Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
timeFrame: Baseline, 3 Months
measure: Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken
timeFrame: Baseline, 3 Months
measure: Patient Global Impression-Improvement (PGI-I) Rating
timeFrame: Month 1 to Month 3
measure: Change from Baseline in the Severity of Remaining Migraine Headaches per Month
timeFrame: Baseline, 3 Months
measure: Change from Baseline in the Number of Monthly Headache Days
timeFrame: Baseline, 3 Months
measure: Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score
timeFrame: Baseline, 3 Months
measure: Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score
timeFrame: Baseline, 3 Months
measure: Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Baseline through 3 Months
measure: Pharmacokinetics (PK): Serum Concentration of Galcanezumab
timeFrame: Baseline through 3 Months
measure: Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
timeFrame: Baseline through 3 Months
measure: Percentage of Participants Developing Anti-Drug Antibodies
timeFrame: Baseline through 3 Months
measure: Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
timeFrame: 16 Months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rehabilitation & Neurological Services
state: Alabama
city: Phoenix
country: United States
facility: 21st Century Neurology, a Division of Xenoscience, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Long Beach
country: United States
facility: Miller Children's & Women's Hospital Long Beach
state: California
city: San Diego
country: United States
facility: Wr-McCr, Llc
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Miami
country: United States
facility: University of Miami Don Suffer Clinical Research Building
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Atlanta
country: United States
facility: Clinical Integrative Research Center of Atlanta, LLC
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Ammon
country: United States
facility: Medical Research Partners
state: Idaho
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Hoffman Estates
country: United States
facility: Inpatient Pharmacy
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Burnsville
country: United States
facility: Minneapolis Clinic of Neurology - Burnsville Office
state: Minnesota
city: Kansas City
country: United States
facility: Children Mercy Pediatric Clinical Research Unit
state: Missouri
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
state: New York
city: Raleigh
country: United States
facility: Velocity Clinical Research at Raleigh Neurology
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence Health & Services
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Office 18
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Houston
country: United States
facility: Pain and Headache Centers of Texas
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
state: Hovedstaden
city: Aalborg
country: Denmark
facility: Sanos Clinic - Nordjylland
state: Nordjylland
city: Essen
country: Germany
facility: Praxis Dr. Astrid Gendolla
state: Nordrhein-Westfalen
city: New Delhi
country: India
facility: G.B. Pant Institute of Postgraduate Medical Education & Research
state: Delhi
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Mangalore
country: India
facility: Mangala Hospital & Mangala Kidney Foundation
state: Karnataka
city: Nagpur
country: India
facility: Getwell Hospital and Research Institute
state: Maharashtra
city: Nagpur
country: India
facility: Central India Cardiology and Research Institute
state: Maharashtra
city: Nagpur
country: India
facility: All India Institute of Medical Sciences (AIIMS) - Nagpur
state: Maharashtra
city: Pune
country: India
facility: Medipoint Hospitals Pvt. Ltd.
state: Maharashtra
city: Roma
country: Italy
facility: Policlinico Umberto I
state: Lazio
city: Milano
country: Italy
facility: IRCCS Istituto Neurologico Carlo Besta
state: Lombardia
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Kobe
country: Japan
facility: Konan Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Yamaguchi Clinic
state: Hyogo
city: Sendai
country: Japan
facility: Sendai Headache and Neurology Clinic
state: Miyagi
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Kochi
country: Japan
facility: Umenotsuji Clinic
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic
city: Osaka
country: Japan
facility: Tominaga Hospital
city: Tokyo
country: Japan
facility: Tokyo Headache Clinic
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research - Guadalajara
state: Jalisco
city: Morelia
country: Mexico
facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales
state: Michoacan
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Medica Aguascalientes (CIMA)
city: Chihuahua
country: Mexico
facility: Unidad de Investigación en Salud
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle
state: Overijssel
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Barcelona [Barcelona]
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
state: Valenciana, Comunitat
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: