No safety signals were identified during the study. 772 individuals completed the study. In the placebo, quarterly fremanezumab, and regular monthly fremanezumab dosing regimens, respectively, individuals had fewer average regular monthly migraine days (mean [standard deviation] change from baseline: ??4.7 [5.4]; ??5.1 [4.7]; ??5.5 [5.0]), month to month headache days of at least moderate severity (??4.5 [5.0]; ??4.8 [4.5]; ??5.2 [4.9]), days per month of acute headache medication use (??4.3 [5.2]; ??4.9 [4.6]; ??4.8 [4.9]), days with photophobia/phonophobia (??3.1 [5.3]; ??3.4 [5.3]; ??4.0 [5.2]), and days with nausea or vomiting (??2.3 [4.6]; ??3.1 [4.5]; ??3.0 [4.4]). During the 12-week open-label extension, 38%, 45%, and 46% of individuals, respectively, Nilvadipine (ARC029) accomplished a?50% reduction and 16%, 15%, and 20%, respectively, accomplished a?75% reduction in monthly migraine days. Disability scores were considerably improved in all 3 treatment organizations. There were low rates of adverse events leading to discontinuation ( 1%). Summary Fremanezumab demonstrated sustained efficacy up to 6?weeks and was well tolerated in individuals with episodic migraine or chronic migraine and documented inadequate response to multiple migraine preventive medication classes. Trial sign up ClinicalTrials.gov “type”:”clinical-trial”,”attrs”:”text”:”NCT03308968″,”term_id”:”NCT03308968″NCT03308968 (FOCUS). double-blind, open-label extension, standard deviation, 6-item Headache Effect Test, Migraine Disability Assessment, revised intent-to-treat aAll individuals in the OLE received fremanezumab 225?mg month to month bOLE mITT analysis collection At baseline, for the Nilvadipine (ARC029) DB placebo, DB quarterly fremanezumab, and DB month to month fremanezumab organizations, the mean (SD) month to month average number of migraine days was 14.4 (6.2), 14.2 (5.6), and KLF5 14.0 (5.5), respectively, and mean (SD) headache days of at least moderate severity was 12.9 (5.9), 12.5 (5.8), and 12.6 (5.7), respectively. At baseline, for the DB placebo, DB quarterly fremanezumab, and DB regular monthly fremanezumab organizations, the imply (SD) days per month of acute medication use was 12.4 (6.3), 12.9 (6.2), and 12.1 (5.9), respectively. At baseline, for the DB placebo, DB quarterly fremanezumab, and DB regular monthly fremanezumab groups, imply (SD) days per month with photophobia/phonophobia was 9.9 (7.8), 9.5 (6.8), and 9.4 (6.8), respectively, and mean (SD) days per month with nausea/vomiting was 6.4 (6.0), 6.7 (5.9), and 6.6 (5.9), respectively. At baseline, for the DB placebo, DB quarterly fremanezumab, and DB regular monthly fremanezumab organizations, the imply (SD) HIT-6 score was 64.1 (4.8) points, 64.3 (4.3) points, and 63.9 (4.5) points, respectively, and mean (SD) MIDAS score was 62.0 (57.4) points, 62.2 (49.3) points, and 61.8 (51.3) points, respectively. Efficacy Over the 12-week DB period, the imply (SD) change from baseline in the regular monthly average number of migraine days was: Nilvadipine (ARC029) placebo, ??1.2 Nilvadipine (ARC029) (4.0); quarterly fremanezumab, ??4.4 (4.2); and regular monthly fremanezumab, ??4.8 (4.4). Over the 12-week OLE, individuals had fewer regular monthly average migraine days (imply [SD] change from baseline: DB placebo, ??4.7 [5.4]; DB quarterly fremanezumab, ??5.1 [4.7]; DB regular monthly fremanezumab, ??5.5 [5.0]; Fig.?2). Open in a separate windowpane Fig. 2 Mean change from BL in the regular monthly average number of migraine days over 6?weeks (mITT).a?BL, baseline; mITT, revised intent-to-treat; DB, double-blind; OLE, open-label extension. aAll individuals in the OLE received fremanezumab 225?mg month to month Over the 12-week DB period, the mean (SD) change from baseline in month to month headache days of at least moderate severity was: placebo, ??1.1 (3.8); quarterly fremanezumab, ??4.3 (4.1); and regular monthly fremanezumab, ??4.7 (4.6). Over the 12-week OLE, individuals also experienced fewer regular monthly headache days of at least moderate severity (imply [SD] change from baseline: placebo, ??4.5 [5.0]; DB quarterly fremanezumab, ??4.8 [4.5]; DB regular monthly fremanezumab, ??5.2 [4.9]; Fig.?3). Open in a separate windowpane Fig. 3 Mean change from BL in the number of headache days of at least moderate severity in the DB period and the OLE (mITT).a BL, baseline; DB, double-blind; OLE, open-label.
