Headache
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Randomized Controlled Trial
Effect of Fremanezumab Monthly and Quarterly Doses on Efficacy Responses.
Exposure-response (E-R) models were developed to provide a description of the time-course of treatment effect for monthly and quarterly dosing regimens of fremanezumab. ⋯ Exposure-response evaluations showed that both monthly (225 mg) and quarterly (675 mg) fremanezumab dosing regimens were appropriate in achieving clinical benefit in adult patients with EM or CM.
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Randomized Controlled Trial Multicenter Study
Evaluation of the Pharmacokinetic Interaction of Ubrogepant Coadministered With Sumatriptan and of the Safety of Ubrogepant With Triptans.
To evaluate the potential for pharmacokinetic interaction and the safety and tolerability when ubrogepant and sumatriptan are coadministered in a Phase 1 study in healthy participants, and to inform the safety and tolerability of ubrogepant alone and in combination with triptans in Phase 3 trials in participants with migraine. ⋯ Although there were slight alterations in ubrogepant pharmacokinetic parameters when coadministered with sumatriptan, such changes are expected to have minimal clinical relevance, especially because no changes were seen in sumatriptan area under the curve and maximum plasma concentration when coadministered with ubrogepant. Coadministration of ubrogepant with sumatriptan was well tolerated in healthy participants in the Phase 1 study, and coadministration of ubrogepant with triptans was well tolerated in participants with migraine in the Phase 3 trials. No new safety concerns for ubrogepant were identified across all trials.
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Randomized Controlled Trial Multicenter Study
Ubrogepant, an Acute Treatment for Migraine, Improved Patient-Reported Functional Disability and Satisfaction in 2 Single-Attack Phase 3 Randomized Trials, ACHIEVE I and II.
To evaluate the efficacy of ubrogepant on patient-reported functional disability, satisfaction with study medication, and global impression of change. ⋯ A significantly higher proportion of participants treated with ubrogepant were able to function normally, were satisfied with the study medication, and reported clinically meaningful improvement compared with those receiving placebo. The results reinforce the potential benefits of ubrogepant on patient-centered outcomes in the acute treatment of migraine.
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Randomized Controlled Trial
Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies.
To evaluate onset of effect of galcanezumab in patients with episodic migraine. ⋯ Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.
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Randomized Controlled Trial
Evaluation of Cardiovascular Outcomes in Adult Patients With Episodic or Chronic Migraine Treated With Galcanezumab: Data From Three Phase 3, Randomized, Double-Blind, Placebo-Controlled EVOLVE-1, EVOLVE-2, and REGAIN Studies.
Blood pressure (BP), pulse, electrocardiogram (ECG), and clinical cardiovascular (CV) outcomes in patients with episodic or chronic migraine treated for up to 6 months with galcanezumab compared to placebo were evaluated. ⋯ In this 6-month treatment trial, the percentages of galcanezumab- and placebo-treated patients that reported CV TEAEs or serious adverse events were low and similar between groups with few discontinuations. Thus, no clinically meaningful treatment group differences were observed for changes in BP, pulse, or ECG parameters. Additional longer-term studies in a broader and larger cohort are required to better characterize CV safety.