scholarly journals 100% Response Rate to Galcanezumab in Patients With Episodic Migraine: A Post Hoc Analysis of the Results From Phase 3, Randomized, Double-Blind, Placebo-Controlled EVOLVE-1 and EVOLVE-2 Studies

2018 ◽  
Vol 58 (9) ◽  
pp. 1347-1357 ◽  
Author(s):  
Noah Rosen ◽  
Eric Pearlman ◽  
Dustin Ruff ◽  
Kathleen Day ◽  
Abraham Jim Nagy
Keyword(s):  
Response Rate ◽  
Episodic Migraine ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis

2019 ◽  
Vol 90 (8) ◽  
pp. 939-944 ◽  
Author(s):  
Peter J Goadsby ◽  
David W Dodick ◽  
James M Martinez ◽  
Margaret B Ferguson ◽  
Tina M Oakes ◽  
...  
Keyword(s):  
Migraine Headache ◽  
Episodic Migraine ◽  
Preventive Effect ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Duration Of Response ◽  
Registration Number ◽  
Post Hoc ◽  
Sustained Responses

Background and objectiveAs new migraine prevention treatments are developed, the onset of a preventive effect, how long it is maintained and whether patients initially non-responsive develop clinically meaningful responses with continued treatment can be assessed.MethodsAnalyses were conducted post-hoc of a double-blind, placebo-controlled, phase II-a study in patients with episodic migraine receiving galcanezumab 150 mg or placebo biweekly for 12 weeks (Lancet Neurol 13:885, 2014). The number of migraine headache days per week, and onset of efficacy measured as the first week galacanezumab separated from placebo were determined. Patients with ≥50%, ≥75% and 100% reduction in migraine headache days from baseline at months 1, 2 and 3 were calculated and defined as sustained responses. Non-responders (<50% response) at month 1 or 2 who then showed ≥50%, ≥75% and 100% response at later time-points were calculated.ResultsPatients were randomised to galcanezumab (n=107) or placebo (n=110). A significant (p=0.018) change of −0.89±0.11 (galcanezumab) vs −0.53±0.11 (placebo) migraine headache days indicated onset at week 1. Forty-seven per cent of galcanezumab and 25% of placebo patients responding at month 1 maintained response through months 2 and 3. Of non-responders at month 1, 27% on galcanezumab and 20% on placebo responded on months 2 and 3, and 50% of galcanezumab non-responders in months 1 and 2 responded on month 3, vs 24% on placebo.ConclusionsThe onset of efficacy of galcanezumab is within 1 week in a majority of patients, and patients receiving galcanezumab are twice more likely to maintain responses than placebo patients. Early non-responders may respond by month 2 or month 3.Trial registration numberNCT01625988.

scholarly journals Impact of Galcanezumab on Total Pain Burden: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Episodic Cluster Headache

2021 ◽  
Vol Volume 14 ◽  
pp. 2059-2070
Author(s):  
J Scott Andrews ◽  
David Kudrow ◽  
Mallikarjuna Rettiganti ◽  
Tina Oakes ◽  
Jennifer N Bardos ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Total Pain ◽  
Episodic Cluster Headache ◽  
Post Hoc
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