Table 1.
Characteristics of the included studies and outcome events.
| Trials | Bigal, 2015 (21) (NCT02021773) | Bigal, 2015 (18) (NCT02025556) | Silberstein et al. (22) (NCT02621931) | Dodick et al. (23) (NCT02629861) | Ferrari et al. (24) (NCT03308968) |
|---|---|---|---|---|---|
| Information of the Included Trials | |||||
| Regions | Multicenter, in USA | Multicenter, in USA | Multicenter, in nine countries | Multicenter, in nine countries | Multicenter, in fifteen countries |
| Phases | IIB/III | IIB/III | III | III | III |
| Eligibility Criteria and Study Design | |||||
| Inclusion Criteria | Chronic migraine Age:18-65 years old No more than 2 different preventive medications or interventions/devices used for migraine. | Episodic migraine Age:18-65 years old No more than 1 preventive medication or intervention/device used for migraine. | Chronic migraine Age:18-70 years old Up to 30% patients were permitted to use no more than 1 concomitant preventive medication | Episodic migraine Age:18-70 years old Up to 30% patients were permitted to use no more than 1 concomitant preventive medication | Chronic migraine and Episodic migraine Age: 18-70 years old Failure from 2-4 different preventive medications using |
| Exclusion Criteria | OnabotulinumtoxinA use more than 6 months before study. Opioids or barbiturate compounds use more than 4 days during the run-in phase. | Opioids or barbiturate compounds use for more than 4 days during the run-in phase | OnabotulinumtoxinA use more than 6 months before study. Opioids or barbiturate compounds use more than 4 days during the run-in phase. | OnabotulinumtoxinA use more than 6 months before study. Opioids or barbiturate compounds use more than 4 days during the run-in phase. | OnabotulinumtoxinA use more than 3 months before study. Opioids or barbiturate compounds use more than 4 days during the run-in phase. |
| Study Design and The Number of Subjects | PBO/PBO/PBO (n = 89) Fremanezumab 675/225/225 mg (n = 88) Fremanezumab 900/900/900 mg (n = 86) | PBO/PBO/PBO (n = 104) Fremanezumab 225/225/225 mg (n = 96) Fremanezumab 675/675/675 mg (n = 97) | PBO/PBO/PBO (n = 371) Fremanezumab 675/PBO/PBO mg (n = 375) Fremanezumab 675/225/225 mg (n = 375) | PBO/PBO/PBO (n = 294) Fremanezumab 675/PBO/PBO mg (n = 291) Fremanezumab 225/225/225 mg (n = 290) | PBO/PBO/PBO (n = 276) Fremanezumab 675/PBO/PBO mg (EM: n = 107; CM: n = 169) Fremanezumab 225/225/225 mg in EM (n = 110) 675/225/225 mg in CM (n = 173) |
| Outcomes Assessments | |||||
| Primary outcomes | Mean change from headache hours of any severity, baseline to week 12 | Mean change from migraine days, baseline to week 12 | Mean change from monthly average headache days of at least moderate severity, baseline to week 12 | Mean change from monthly average migraine days, baseline to week 12 | Mean change from monthly average migraine days, baseline to week 12 |
| Safety outcomes | Serious adverse events, Injection-site reactions, Headache, Infections,etc. | Serious adverse events, Injection-site reactions, Headache, Infections,etc. | At least one adverse event At least one adverse event related to the trial regimen At least one serious adverse event. Injection-site reactions, Infections, Dizziness, Nausea, etc. | At least one adverse event At least one adverse event related to the trial regimen At least one serious adverse event. Injection-site reactions, Infections, Gastrointestinal disorders, etc. | At least one adverse event At least one adverse event related to the trial regimen At least one serious adverse event. Injection-site reactions, Infections, Gastrointestinal disorders, etc. |