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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
312
Administered SQ
Administered SQ
Change from Baseline in the Number of Monthly Migraine Headache Days
Change from Baseline in the Number of Monthly Migraine Headache Days
Time frame: Baseline, 3 Months
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Time frame: 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 Nausea and/or Vomiting
Time frame: 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 Headache Days with Photophobia and Phonophobia
Time frame: Baseline, 3 Months
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
Time frame: Baseline, 3 Months
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken
Time frame: Baseline, 3 Months
Patient Global Impression-Improvement (PGI-I) Rating
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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
Children's Hospital Colorado
Aurora, Colorado, United States
Northwest Florida Clinical Research Group
Gulf Breeze, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
Vitaly Clinical Research
Miami, Florida, United States
EMDA Clinical Research
Miami, Florida, United States
...and 78 more locations
PGI-I Rating
Time frame: Month 1 to Month 3
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Time frame: Baseline, 3 Months
Change from Baseline in the Number of Monthly Headache Days
Change from Baseline in the Number of Monthly Headache Days
Time frame: Baseline, 3 Months
Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score
Change from Baseline on the PedsQL Total Score
Time frame: Baseline, 3 Months
Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score
Change from Baseline on the PedMIDAS Total Score
Time frame: Baseline, 3 Months
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
Time frame: Baseline through 3 Months
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
PK: Serum Concentration of Galcanezumab
Time frame: Baseline through 3 Months
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of CGRP
Time frame: Baseline through 3 Months
Percentage of Participants Developing Anti-Drug Antibodies
Percentage of Participants Developing Anti-Drug Antibodies
Time frame: Baseline through 3 Months
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
Time frame: 16 Months