Search

Your search keyword '"Grozinski‐Wolff, Melissa"' showing total 14 results
Start Over Author "Grozinski‐Wolff, Melissa"
14 results on '"Grozinski‐Wolff, Melissa"'

5. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS):a randomised, double-blind, placebo-controlled, phase 3b trial

Author

Ferrari, Michel D., Diener, Hans Christoph, Ning, Xiaoping, Galic, Maja, Cohen, Joshua M., Yang, Ronghua, Mueller, Matthias, Ahn, Andrew H., Schwartz, Yael Carmeli, Grozinski-Wolff, Melissa, Janka, Lindsay, Ashina, Messoud, Ferrari, Michel D., Diener, Hans Christoph, Ning, Xiaoping, Galic, Maja, Cohen, Joshua M., Yang, Ronghua, Mueller, Matthias, Ahn, Andrew H., Schwartz, Yael Carmeli, Grozinski-Wolff, Melissa, Janka, Lindsay, and Ashina, Messoud

Abstract

Background: Antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor have shown efficacy in the prevention of migraine attacks. We investigated the efficacy and tolerability of fremanezumab, a fully humanised CGRP antibody, in patients with migraine who had previously not responded to two to four classes of migraine preventive medications. Methods: The randomised, double-blind, placebo-controlled, parallel-group, phase 3b FOCUS trial was done at 104 sites (including hospitals, medical centres, research institutes, and group practice clinics) across Belgium, the Czech Republic, Denmark, Finland, France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, the UK, and the USA. We enrolled participants aged 18–70 years with episodic or chronic migraine who had documented failure to two to four classes of migraine preventive medications in the past 10 years. Failure was defined as no clinically meaningful improvement after at least 3 months of therapy at a stable dose, as per the treating physician's judgment; discontinuation because of adverse events that made treatment intolerable; or treatment contraindicated or unsuitable for the preventive treatment of migraine for the patient. Participants were randomly assigned (1:1:1) by electronic interactive response technology to subcutaneously administered quarterly fremanezumab (month 1, 675 mg; months 2 and 3: placebo), monthly fremanezumab (month 1: 225 mg in episodic migraine and 675 mg in chronic migraine; months 2 and 3: 225 mg in both migraine subgroups), or matched monthly placebo for 12 weeks. The primary outcome was mean change from baseline in the monthly average number of migraine days during the 12-week treatment period. This trial is registered with ClinicalTrials.gov, number NCT03308968, and is now completed. Findings: Between Nov 10, 2017, and July 6, 2018, 838 participants with episodic (329 [39%]) or chronic (509 [61%]) migraine were randomly assigned to placebo (n=279)

Published
2019

12. Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine (P4.093)

Author

Dodick, David, primary, Aycardi, Ernesto, additional, Bigal, Marcelo, additional, Yeung, Paul P., additional, Blankenbiller, Tricia, additional, Grozinski-Wolff, Melissa, additional, Yang, Ronghua, additional, Ma, Yuju, additional, Silberstein, Stephen, additional, and Goadsby, Peter J., additional

Published
2018
Full Text
View/download PDF

14. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine.

Author

Brandes, Jan Lewis, Kudrow, David, Yeung, Paul P, Sakai, Fumihiko, Aycardi, Ernesto, Blankenbiller, Tricia, Grozinski-Wolff, Melissa, Yang, Ronghua, and Ma, Yuju

Subjects
*MIGRAINE, *CALCITONIN gene-related peptide, *HEADACHE, *DRUGS, *MONOCLONAL antibodies
Abstract

Background: Fremanezumab, a fully humanized monoclonal antibody targeting calcitonin gene-related peptide, has demonstrated efficacy for the preventive treatment of migraine in adults. Objective: To evaluate the effect of fremanezumab treatment on acute headache medication use and migraine-associated symptoms in patients with episodic migraine. Methods: In the Phase 3 HALO trial, patients with episodic migraine were randomized to receive subcutaneous fremanezumab monthly (225 mg at baseline, weeks 4 and 8), fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), or placebo over a 12-week period. The secondary endpoint was change from baseline in the monthly number of days with use of any acute headache mediation or migraine-specific acute headache medication; exploratory endpoints were change from baseline in the monthly number of days with nausea or vomiting, photophobia, or phonophobia. Results: Of 875 patients randomized, 865 were included in the analysis (monthly, n = 287; quarterly, n = 288; placebo, n = 290). Baseline mean ± standard deviation days with: Any acute headache medication use (monthly: 7.7 ± 3.4; quarterly: 7.8 ± 3.7; placebo: 7.7 ± 3.6), migraine-specific acute headache medication use (6.1 ± 3.1; 6.6 ± 3.1; 7.1 ± 3.0), nausea or vomiting (4.5 ± 3.6; 4.9 ± 3.7; 4.5 ± 3.3) and photophobia and phonophobia (5.5 ± 4.1; 6.3 ± 4.1; 6.0 ± 3.9) were similar among treatment arms. Fremanezumab reduced the number of days of acute headache medication use ([least-squares mean change vs. placebo] monthly: −1.4 [95% confidence interval: −1.84, −0.89], p < 0.001; quarterly: −1.3 [−1.76, −0.82], p < 0.001) and migraine-specific acute headache medication use (monthly: −2.2 [−2.80, −1.56], p < 0.001; quarterly: −2.2 [−2.81, −1.58], p < 0.001) compared with placebo. Fremanezumab also reduced nausea or vomiting, photophobia, and phonophobia compared with placebo. Conclusions: Fremanezumab reduced the need for acute headache medications, including migraine-specific medications, while treating migraine-associated symptoms in patients with episodic migraine. Trial registration: Clinicaltrials.gov NCT02629861 [ABSTRACT FROM AUTHOR]

Published
2020
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results