Clinical trial NCT04616326: A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Migraine
Keywords: pediatric
children
prevention
prophylaxis
headache
pediatric migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 300
Sex: ALL
Minimum age (years): 12
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 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.

Detailed description: 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.

Eligibility criteria: 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.

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 ≥30%, ≥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 Monthly 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: 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: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Gulf Breeze
country: United States
facility: Northwest Florida Clinical Research Group
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research
state: Florida
city: Miami
country: United States
facility: Vitaly Clinical Research
state: Florida
city: Miami
country: United States
facility: EMDA Clinical Research
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Tamarac
country: United States
facility: D&H Tamarac Research Center
state: Florida
city: Tamarac
country: United States
facility: Infinity Life Research Group
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Ammon
country: United States
facility: Medical Research Partners
state: Idaho
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Hoffman Estates
country: United States
facility: St. Alexius Medical Center
state: Illinois
city: Wichita
country: United States
facility: Ascension Via Christi Research
state: Kansas
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: 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: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Ridgeland
country: United States
facility: Proven Endpoints
state: Mississippi
city: Kansas City
country: United States
facility: Children Mercy Pediatric Clinical Research Unit
state: Missouri
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
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: Cincinnati
country: United States
facility: Headache Center of Hope
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: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Nashville
country: United States
facility: Access Clinical Trials - Nashville
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Lewisville
country: United States
facility: Prime Clinical Research - Lewisville
state: Texas
city: Logan
country: United States
facility: Medical Research Partners - Logan
state: Utah
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: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
state: Bouches-du-Rhône
city: Bordeaux
country: France
facility: Bordeaux University Hospital - Pellegrin
state: Gironde
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
state: Nord-Pas-de-Calais
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
state: Paris
city: Amiens
country: France
facility: CHU d'Amiens-Picardie - Hôpital Sud
state: Somme
city: Paris
country: France
facility: Hôpital Armand Trousseau
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: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Apollo Hospitals Ahmedabad
state: Gujarat
city: Gurugram
country: India
facility: Artemis hospital
state: Haryana
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: Department of Pediatrics
state: Maharashtra
city: Pune
country: India
facility: Medipoint Hospitals Pvt. Ltd.
state: Maharashtra
city: Kanpur
country: India
facility: Atmaram Child Care
state: Uttar Pradesh
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: Neuroscience
city: Kobe
country: Japan
facility: Konan Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Yamaguchi Clinic
state: Hyogo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgery&Headache Clinic
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: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
state: Distrito Federal
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: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
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: