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Table 1 Characteristics of the Included Studies and Outcome Events

From: Different doses of galcanezumab versus placebo in patients with migraine and cluster headache: a meta-analysis of randomized controlled trials

Trials Phases Publication CenterInclusion CriteriaExclusion CriteriaConditiongroupFrequency
Oakes, 2018(NCT02163993) [14]
Phase2b
Cephalalgia
Multicenter
Aged 18–65 years
A diagnosis of episodic migraine for at least 1 year prior
Monthly frequency of 4–14 MHD
Failure to respond to three or more adequately dosed effective migraine prevention treatments
Prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to NGF
History of migraine subtypesa
Episodic migrainegalcanezumab 5 mg
galcanezumab 50 mg
galcanezumab 120 mg
galcanezumab 300 mg
placebo
Once a month for 3 months
Stauffer, 2018(NCT02614183) [15]
Phase 3
JAMA Neurology
Multicenter
Aged 18–65 years
A diagnosis of episodic migraine for at least 1 year prior
Monthly frequency of 4–14 MHD
Failure to respond to three or more classes of migraine preventive treatments
Prior exposure to any CGRP antibody
Having taken a therapeutic antibody in the past 12 months
Receiving preventive migraine medication within 30 days
History of persistent daily headache, cluster headache or migraine subtypes
Episodic migrainegalcanezumab 120 mg (with 240-mg loading dose)
galcanezumab 240 mg
placebo
Once a month for 6 months
Skljarevski, 2018(NCT02614196) [16]
Phase 3
Cephalalgia
Multicenter
Aged 18–65 years
A diagnosis of episodic migraine for at least 1 year prior
Monthly frequency of 4–14 MHD and at least two migraine attacks during the baseline period
Failure to respond to three or more classes of migraine preventive treatments
Prior exposure to any CGRP antibody
Having taken a therapeutic antibody in the past 12 months
Using opioids or barbiturates more than twice per month
Known hypersensitivity to multiple drugs
Episodic migrainegalcanezumab 120 mg
galcanezumab 240 mg
placebo
Once a month for 6 months
Dodick, 2014 (NCT01625988) [19]
Phase 2
Lancet Neurol
Multicenter
Aged 18–65 years
A diagnosis of migraine as defined by IHS ICHD-II for at least 1 year prior
Monthly frequency of 4–14 MHD
Failure to respond to three or more adequately dosed approved migraine prevention treatments
Receiving preventive migraine medication within 30 days, including receiving botulinum toxin within 4 months
History of chronic migraine or migraine subtypes
Patients with at least 15 headache days per 28-day period
Episodic migrainegalcanezumab 150 mg
placebo
Once every 2 weeks for 12 weeks
Trials Phases Publication CenterInclusion CriteriaExclusion CriteriaConditiongroupFrequency
Detke, 2018(NCT02614261) [17]
Phase 3
Neurology
Multicenter
Aged 18–65 years
A diagnosis of chronic migraine for at least 1 year prior
A history of at least 15 headache days per month, of which at least 8 were migraine and a history of at least 1 headache-free day per month for the past 3 months
Failure to respond to three or more classes of migraine preventive treatments
Prior exposure to any CGRP antibody
Having taken a therapeutic antibody in the past 12 months
Persistent daily headache, cluster headache, head or neck trauma within the past 6 months, possible posttraumatic headache, or primary headache other than chronic migraine
Receiving preventive migraine medication within 30 days, including receiving botulinum toxin within 4 months
Chronic migrainegalcanezumab 120 mg (with 240-mg loading dose)
galcanezumab 240 mg
placebo
Once a month for 3 months
Camporeale, 2018(NCT02614287) [20]
Phase 3
BMC Neurology
Multi-center
Aged 18–65 years
A diagnosis of migraine for at least 1 year prior
A history of 4 or more MHD per month on average for the past 3 months and a history of at least 1 headache-free day per month for the past 3 months
Failure to respond to three or more classes of migraine preventive treatments
Prior exposure to galcanezumab or any other CGRP antibody
Having taken a therapeutic antibody in the past 12 months
Current treatment with preventive migraine medication
Chronic and episodic migrainegalcanezumab 120 mg (with 240-mg loading dose)
galcanezumab 240 mg
Once a month for 12 months
Goadsby, 2019(NCT02397473) [18]
Phase 3
N Engl J Med
Multicenter
Aged 18–65 years
A diagnosis of cluster headache
Frequency of at least one attack every other day, at least four total attacks, and no more than eight attacks per day during a baseline assessment
A history of cluster headache periods lasting at least 6 weeks
Participants are able to distinguish cluster headache attacks from other headaches
Prior exposure to any CGRP antibody, antibody to the CGRP receptor or antibody to NGF
Concurrent use of other therapeutic monoclonal antibodies
Having another distinct trigeminal autonomic cephalalgia or a history of migraine variants that could have been due to cerebral ischemia
Episodic cluster headachegalcanezumab 300 mg
placebo
Once a month for 2 months
  1. MHD Migraine Headache Days, CGRP calcitonin-gene-related peptide, NGF nerve growth factor;
  2. aMigraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine
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