Background
Methods
Search strategy
Study selection
Data extraction
Statistical analysis
Risk of Bias
Results
Search results and study characteristics
Trials Phases Publication Center | Inclusion Criteria | Exclusion Criteria | Condition | group | Frequency |
---|---|---|---|---|---|
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 migraine | galcanezumab 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 migraine | galcanezumab 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 migraine | galcanezumab 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 migraine | galcanezumab 150 mg placebo | Once every 2 weeks for 12 weeks |
Trials Phases Publication Center | Inclusion Criteria | Exclusion Criteria | Condition | group | Frequency |
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 migraine | galcanezumab 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 migraine | galcanezumab 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 headache | galcanezumab 300 mg placebo | Once a month for 2 months |
Quality assessment
Efficacy
Efficacy | Safety | |||||
---|---|---|---|---|---|---|
50% ≥ response | MHD | TEAE | ||||
RR (95% CI) | P value | WMD (95% CI) | P value | RR (95% CI) | P value | |
1. 120 mg Galcanezumab | ||||||
3 months | 1.469 (1.166, 1.850) | 0.006 | −2.090 (−3.237, − 0.943) | 0.000 | 1.144 (1.003, 1.304) | 0.045 |
6 months | 1.513 (1.286, 1.779) | 0.013 | −1.774 (−2.256, − 1.291) | 0.000 | 1.033 (0.950, 1.123) | 0.443 |
2. 240 mg Galcanezumab | ||||||
3 months | 1.589 (1.270, 1.987) | 0.013 | −1.880 (−2.983, −0.777) | 0.001 | 1.155 (1.014, 1.316) | 0.030 |
6 months | 1.582 (1.406, 1.780) | 0.000 | −1.839 (−2.324, − 1.354) | 0.000 | 1.170 (1.082, 1.266) | 0.000 |
3. 300 mg Galcanezumab | ||||||
1 month | N/A | N/A | N/A | N/A | 1.286 (0.788, 2.097) | 0.314 |
3 months | 1.509 (1.166, 1.954) | 0.000 | −1.200 (−2.012, −0.388) | 0.004 | 1.087 (0.927, 1.275) | 0.302 |
6 months | 1.147 (0.928, 1.418) | 0.000 | −0.620 (−1.565, 0.325) | 0.198 | 0.935 (0.693, 1.261) | 0.659 |
Tolerance, adverse effect, and adherence
3 month | 6 month | 12 month | |
---|---|---|---|
Placebo | 9.28% | 16.78% | N/A |
Treatment | 5.74% | 14.24% | 22.22% |