A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
- Registration Number
- NCT04616326
- Lead Sponsor
- Eli Lilly and Company
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period. Galcanezumab Galcanezumab Galcanezumab 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 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
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
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 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
Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days 3 Months Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken 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 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 Severity of Remaining Migraine Headaches per Month Baseline, 3 Months Change from Baseline in the Severity of Remaining Migraine Headaches per Month
Patient Global Impression-Improvement (PGI-I) Rating Month 1 to Month 3 PGI-I Rating
Change from Baseline in the Number of Monthly Headache Days Baseline, 3 Months Change from Baseline in the Number of Monthly Headache Days
Pharmacokinetics (PK): Serum Concentration of Galcanezumab Baseline through 3 Months PK: Serum Concentration of Galcanezumab
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) Baseline through 3 Months Plasma Concentration of CGRP
Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score Baseline, 3 Months Change from Baseline on the PedMIDAS Total Score
Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score Baseline, 3 Months Change from Baseline on the PedsQL Total Score
Percentage of Participants Developing Anti-Drug Antibodies Baseline through 3 Months Percentage of Participants Developing Anti-Drug Antibodies
Trial Locations
- Locations (88)
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
Wellness Clinical Research
🇺🇸Miami Lakes, Florida, United States
Vitaly Clinical Research
🇺🇸Miami, Florida, United States
Scroll for more (78 remaining)Rehabilitation & Neurological Services🇺🇸Huntsville, Alabama, United StatesBelinda Savage-Edwards, MDPrincipal Investigator