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. 2023 Jun 30;11(2):e167. doi: 10.15190/d.2023.6

Table 2. Outcomes in Major Clinical Trials for Atogepant.

OD: Once daily, BID: Twice daily, SD - Single Dose, CFB change from baseline, MMDs monthly migraine days, MHDs monthly headache days, TRAEs treatment-related adverse events, SAEs serious adverse events, OR odds ratio, CI confidence interval*p <0.05, **p<0.001, vs. placebo; aThe data are presented as difference from Placebo

Study Doses CFB in MMDs after 12 weeks (95% CI)a CFB in MHDs after 12 weeks (95% CI)a ≥ 50% reduction in MMDs (%) (OR, 95% CI) CFB in acute medication use days (95% CI)a Incidence of TRAEs (%) Incidence of SAEs (%) Drug discontinuation rate (%)
Ankrom et al.9 60 mg OD - - - - 23.3 0 15.3
Goadsby et al.10 10 mg OD − 1.2* (− 1.9 to − 0.4) − 1.4* (− 2.2 to – 0.5) 1.5 (1 to 2.3) − 1.3 (− 2.0 to − 0.6) 18 0 4
30 mg OD − 0.9* (− 1.6 to − 0.3) − 1.2* (− 1.9 to − 0.6 1.5 (1 to 2.1) − 1.4 (− 2.0 to − 0.9) 21 0 6
60 mg OD − 0.7* (− 1.4 to − 0.1) − 0.9* (− 1.6 to − 0.2) 1.4 (1 to 2) − 1.1 (− 1.7 to − 0.5) 23 0 3
30 mg BID − 1.4* (− 2.2 to − 0.6) − 1.3* (− 2.2 to − 0.4) 1.8* (1.2 to 2.9) − 1.4* (− 2.1 to − 0.6) 21 0 6
60 mg BID − 1.3* (− 2.1 to − 0.5) − 1.4* (− 2.3 to − 0.5) 2.0* (1.3 to 3.2) − 1.2* (− 1.9 to − 0.5) 26 0 8
Placebo - - - - 16 0 3
Min et al.11 170 mg OD - - - - 87 0 8.7
Placebo - - - - 72.7 0 0
Boinpally et al.12 300 mg SD - - - - 1.7 0 0
Placebo - - - - - - -
Ailani et al.13, Schwedt et al.14, and Lipton et al.15 10 mg OD − 1.2** (− 1.8 to − 0.6) − 1.4** (− 2.0 to − 0.8) 3.1** (2 to 4.6) − 1.3** (− 1.8 to − 0.8) 23.1 0.5 4.1
30 mg OD − 1.9** (− 1.9 to –0.8) − 1.5** (− 2.1 to− 1.1) 3.5** (2. 4 to 5.3) − 1.3** (− 1.8 to − 0.8) 14.9 0 1.8
60 mg OD − 1.7** (− 2.3 to − 1.2) − 1.7** (− 2.3 to − 1.1) 3.8** (2.6 to 5.7) − 1.5** (− 2.0 to − 1.0) 19.5 0 2.6
Placebo - - - - 9 0 2.7
Klein et al.16 60 mg OD - - - - 8.8 3.4 25.4 (after open label treatment period) and 27.7 (at safety follow-up period)
Ashina et al.17 60 mg OD - - 84.2 - 18 4.4 31.6
Placebo - - - - 36.2 3.6 31.2