Chronic Migraine MedDRA version: 21.1 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 100000004852
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 310 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, other than antibodies to calcitonin gene-related peptide (CGRP) or its receptor, 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. Patients must also not have prior oral CGRP antagonist use within 30 days prior to Visit 2. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17 year-olds) with chronic migraine;Secondary Objective: to evaluate the efficacy and safety of galcanezumab;Primary end point(s): 1. Change from Baseline in the Number of Monthly Migraine Headache Days;Timepoint(s) of evaluation of this end point: 1. Time Frame: Baseline, 3 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Percentage of Participants with Reduction from Baseline =50%, =75% and 100% in Monthly Migraine Headache Days 3. Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting 4. Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia 5. Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms 6. Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken 7. Patient Global Impression-Improvement (PGI-I) Rating 8. Change from Baseline in the Severity of Remaining Migraine Headaches per Month 9. Change from Baseline in the Number of Monthly Headache Days 10. Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score 11. Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score 12. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score 13. Pharmacokinetics (PK): Serum Concentration of Galcanezumab 14. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) 15. Percentage of Participants Developing Anti-Drug Antibodies 16. Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase;Timepoint(s) of evaluation of this end point: 2. Time Frame: 3 Months 3. Time Frame: Baseline, 3 Months 4. Time Frame: Baseline, 3 Months 5. Time Frame: Baseline, 3 Months 6. Time Frame: Baseline, 3 Months 7. Time Frame: Month 1 to Month 3 8. Time Frame: Baseline, 3 Months 9. Time Frame: Baseline, 3 Months 10. Time Frame: Baseline, 3 Months 11. Time Frame: Baseline, 3 Months 12. Time Frame: Baseline through 3 Months 13. Time Frame: Baseline through 3 Months 14. Time Frame: Baseline through 3 Months 15. Time Frame: Baseline through 3 Months 16. Time Frame: 16 Months | — |
Countries
Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Spain, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed