A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
- Registration Number
- NCT03432286
- Lead Sponsor
- Eli Lilly and Company
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 325
- 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.
- 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Galcanezumab Galcanezumab Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period. Placebo Placebo Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
- Primary Outcome Measures
Name Time Method Change from Baseline in the Number of Monthly Migraine Headache Days Baseline, 3 Months Change from baseline in the number of monthly migraine headache days
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days 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 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 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 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 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 Month 1 to Month 3 PGI-I rating
Change from Baseline in the Severity of Remaining Migraine Headaches per Month 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 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 Baseline, 3 Months Change from Baseline on the PedsQL total score
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) Baseline through 3 Months Plasma concentration of CGRP
Percentage of Participants Developing Anti-Drug Antibodies 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 16 Months Percentage of participants who initiate migraine prevention medication in the post-treatment follow-up phase
Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score 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 Baseline through 3 Months Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score
Pharmacokinetics (PK): Serum Concentration of Galcanezumab Baseline through 3 Months PK: Serum concentration of galcanezumab
Trial Locations
- Locations (73)
Tokyo Headache Clinic
🇯🇵Tokyo, Japan
Rehabilitation & Neurological Services
🇺🇸Huntsville, Alabama, United States
21st Century Neurology, a Division of Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Center for Neurosciences
🇺🇸Tucson, Arizona, United States
Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Wr-McCr, Llc
🇺🇸San Diego, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Jacksonville, Florida, United States
University of Miami Don Suffer Clinical Research Building
🇺🇸Miami, Florida, United States
Ezy Medical Research
🇺🇸Miami, Florida, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
USF Health
🇺🇸Tampa, Florida, United States
Premiere Research Institute at Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Clinical Integrative Research Center of Atlanta, LLC
🇺🇸Atlanta, Georgia, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
Medical Research Partners
🇺🇸Ammon, Idaho, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Inpatient Pharmacy
🇺🇸Hoffman Estates, Illinois, United States
University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Minneapolis Clinic of Neurology - Burnsville Office
🇺🇸Burnsville, Minnesota, United States
Children Mercy Pediatric Clinical Research Unit
🇺🇸Kansas City, Missouri, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
🇺🇸New Hyde Park, New York, United States
Velocity Clinical Research at Raleigh Neurology
🇺🇸Raleigh, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Providence Health & Services
🇺🇸Portland, Oregon, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Office 18
🇺🇸Pittsburgh, Pennsylvania, United States
Velocity Clinical Research, Providence
🇺🇸East Greenwich, Rhode Island, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Pain and Headache Centers of Texas
🇺🇸Houston, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Herlev and Gentofte Hospital
🇩🇰Copenhagen, Hovedstaden, Denmark
Sanos Clinic - Nordjylland
🇩🇰Aalborg, Nordjylland, Denmark
Praxis Dr. Astrid Gendolla
🇩🇪Essen, Nordrhein-Westfalen, Germany
G.B. Pant Institute of Postgraduate Medical Education & Research
🇮🇳New Delhi, Delhi, India
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Mangala Hospital & Mangala Kidney Foundation
🇮🇳Mangalore, Karnataka, India
Getwell Hospital and Research Institute
🇮🇳Nagpur, Maharashtra, India
Central India Cardiology and Research Institute
🇮🇳Nagpur, Maharashtra, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
🇮🇳Nagpur, Maharashtra, India
Medipoint Hospitals Pvt. Ltd.
🇮🇳Pune, Maharashtra, India
Policlinico Umberto I
🇮🇹Roma, Lazio, Italy
IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
Ospedale Pediatrico Bambino Gesù
🇮🇹Roma, Italy
Konan Hospital
🇯🇵Kobe, Hyogo, Japan
Yamaguchi Clinic
🇯🇵Nishinomiya, Hyogo, Japan
Sendai Headache and Neurology Clinic
🇯🇵Sendai, Miyagi, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Umenotsuji Clinic
🇯🇵Kochi, Japan
Tatsuoka Neurology Clinic
🇯🇵Kyoto, Japan
Tominaga Hospital
🇯🇵Osaka, Japan
Hospital Civil Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
PanAmerican Clinical Research - Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
Clinica De Enfermedades Cronicas y Procedimientos Especiales
🇲🇽Morelia, Michoacan, Mexico
Centro de Investigacion Medica Aguascalientes (CIMA)
🇲🇽Aguascalientes, Mexico
Unidad de Investigación en Salud
🇲🇽Chihuahua, Mexico
Isala, locatie Zwolle
🇳🇱Zwolle, Overijssel, Netherlands
Dr. Samuel Sanchez PSC
🇵🇷Caguas, Puerto Rico
Ponce Medical School Foundation Inc.
🇵🇷Ponce, Puerto Rico
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Clinico de Valencia
🇪🇸Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain