migraine prevention
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Cephalalgia ◽  
2022 ◽  
pp. 033310242110688
Author(s):  
Umer Najib ◽  
Timothy Smith ◽  
Nada Hindiyeh ◽  
Joel Saper ◽  
Barbara Nye ◽  
...  

Aim Evaluate the efficacy and safety of non-invasive vagus nerve stimulation for migraine prevention. Methods After completing a 4-week diary run-in period, adults who had migraine with or without aura were randomly assigned to receive active non-invasive vagus nerve stimulation or sham therapy during a 12-week double-blind period. Results Of 336 enrolled participants, 113 (active, n = 56; sham, n = 57) completed ≥70 days of the double-blind period and were ≥66% adherent with treatment, comprising the prespecified modified intention-to-treat population. The COVID-19 pandemic led to early trial termination, and the population was ∼60% smaller than the statistical target for full power. Mean reduction in monthly migraine days (primary endpoint) was 3.12 for the active group and 2.29 days for the sham group (difference, −0.83; p = 0.2329). Responder rate (i.e. the percentage of participants with a ≥50% reduction in migraine days) was greater in the active group (44.87%) than the sham group (26.81%; p = 0.0481). Prespecified subgroup analysis suggested that participants with aura responded preferentially. No serious device-related adverse events were reported. Conclusions These results suggest clinical utility of non-invasive vagus nerve stimulation for migraine prevention, particularly for patients who have migraine with aura, and reinforce the well-established safety and tolerability profile of this therapy. Trial Registration: ClinicalTrials.gov (NCT03716505).


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Raffaele Ornello ◽  
Valeria Caponnetto ◽  
Susanna Ratti ◽  
Giulia D’Aurizio ◽  
Chiara Rosignoli ◽  
...  

Abstract Background Transcranial direct current stimulation (tDCS) could counteract the pathophysiological triggers of migraine attacks by modulating cortical excitability. Several pilot randomized controlled trials (RCTs) assessed the efficacy of tDCS for migraine prevention. We reviewed and summarized the state of the art of tDCS protocols for migraine prevention, discussing study results according to the stimulations parameters and patients’ populations. Main body We combined the keywords ‘migraine’, ‘headache’, ‘transcranial direct current stimulation’, and ‘tDCS’ and searched Pubmed, Scopus, and Web of Science, from the beginning of indexing to June 22, 2021. We only included RCTs comparing the efficacy of active tDCS with sham tDCS to decrease migraine frequency, intensity, and/or acute drug utilization. The risk of bias of each RCT was assessed by using the RoB-2 tool (Cochrane Collaboration). Thirteen RCTs (from 2011 to 2021) were included in the review. The included patients ranged from 13 to 135. RCTs included patients with any migraine (n=3), chronic migraine (n=6), episodic migraine (n=3) or menstrual migraine (n=1). Six RCTs used cathodal and five anodal tDCS, while two RCTs compared the efficacy of both cathodal and anodal tDCS with that of sham. In most of the cathodal stimulation trials, the target areas were the occipital regions, with reference on central or supraorbital areas. In anodal RCTs, the anode was usually placed above the motor cortical areas and the cathode on supraorbital areas. All RCTs adopted repeated sessions (from 5 to 28) at variable intervals, while the follow-up length spanned from 1 day up to 12 months. Efficacy results were variable but overall positive. According to the RoB-2 tool, only four of the 13 RCTs had a low risk of bias, while the others presented some concerns. Conclusions Both anodal and cathodal tDCS are promising for migraine prevention. However, there is a need for larger and rigorous RCTs and standardized procedures. Additionally, the potential benefits and targeted neurostimulation protocols should be assessed for specific subgroups of patients.


Author(s):  
DW Dodick

Background: Eptinezumab is approved in the US for migraine prevention. We demonstrate the consistency in migraine reduction from Day 1 across 4 weeks in patients with episodic (EM) or chronic migraine (CM) treated with eptinezumab. Methods: Four double-blind, placebo-controlled, randomized trials evaluated eptinezumab for migraine prevention: NCT01772524 (EM); NCT02559895 (EM, PROMISE-1); NCT02275117 (CM); NCT02974153 (CM, PROMISE-2). The percentage of patients experiencing migraine was evaluated on Day 1, then as an averaged daily occurrence weekly through Wk4; baseline was averaged over the 28-day screening period. Results: Approximately 31% of EM patients experienced migraine on any given day during baseline. PROMISE-1 percentages of patients with migraine on Day 1: 14.8% (100mg), 13.9% (300mg), 22.5% (placebo); during Wk4: 17.1%, 15.8%, 20.5%. NCT01772524 on Day 1: 4.8% (1000mg), 13.7% (placebo); during Wk4: 10.0%, 17.6%. Approximately 58-59% of CM patients experienced migraine on any given day during baseline. PROMISE-2 percentages on Day 1: 28.6% (100mg), 27.8% (300mg), 42.3% (placebo); during Wk4: 31.8%, 28.8%, 36.0%. NCT02275117 on Day 1: 29.3% (100mg), 26.5% (300mg), 48.7% (placebo); during Wk4: 30.2%, 30.1%, 41.0%. Conclusions: Across 4 migraine prevention trials, eptinezumab consistently demonstrated rapid onset of migraine preventive benefit, beginning Day 1 after initial treatment and sustained through ≥4 weeks.


Author(s):  
Adrián Viudez-Martinez ◽  
Angela Pascual-Carrasco ◽  
Isabel Beltrán Blasco ◽  
Raquel Hernandez-Lorido ◽  
Rosa Fuster-Ruiz-de-Apodaca

Aim and Methods: Erenumab and galcanezumab have shown great results for migraine prevention in several clinical trials. However, strict inclusion criteria, absence of concomitant medication and selective outcome report may sometimes be barely representative of the real-world daily practice. Therefore, this observational, retrospective, non-comparative study was aimed to evaluate the effectiveness and safety of erenumab 140 mg and galcanezumab 120 mg in real-world patients with difficult-to-treat episodic or chronic migraine, who previously did not respond to up to three well-stablished pharmacological alternatives for migraine prevention. A combination of objective well-defined tools and vastly used patient reported outcome measurements were evaluated at baseline and after the administration of 3 and 6 doses. Results: from 180 patients, 142 matched inclusion criteria for the present study. Data here reported shows that erenumab and galcanezumab reduced mean headache days, acute migraine specific medication days, Headache Impact Test score, Migraine Disability Assessment Test score and Visual Analogue Scale score after 3 and 6 doses in real-world patients diagnosed with difficult to treat chronic or episodic migraine (p<0.01). Moreover, acute migraine specific medication days were reduced by a half in, at least, a 50% of the patients enrolled in each of the groups of the study. Both treatments exhibited a great safety profile, rarely leading to discontinuation because of poor tolerance. Conclusions: Erenumab and galcanezumab seem effective and well tolerated for migraine prevention in real-world patients with episodic or chronic migraine who previously failed to oral preventive therapies.


Cephalalgia ◽  
2021 ◽  
pp. 033310242110335
Author(s):  
Brooke L Reidy ◽  
James Peugh ◽  
Andrew D Hershey ◽  
Christopher S Coffey ◽  
Leigh A Chamberlin ◽  
...  

Objective Identify preventive medication treatment response trajectories among youth participating in the Childhood and Adolescent Migraine Prevention study. Methods Data were evaluated from 328 youth (ages 8–17). Childhood and Adolescent Migraine Prevention study participants completed headache diaries during a 28-day baseline period and a 168-day active treatment period during which youth took amitriptyline, topiramate, or placebo. Daily headache occurrence trajectories were established across baseline and active treatment periods using longitudinal hierarchical linear modeling. We tested potential treatment group differences. We also compared final models to trajectory findings from a clinical trial of cognitive behavioral therapy plus amitriptyline for youth with chronic migraine to test for reproducibility. Results Daily headache occurrence showed stability across baseline. Active treatment models revealed decreases in headache frequency that were most notable early in the trial period. Baseline and active treatment models did not differ by treatment group and replicated trajectory cognitive behavioral therapy plus amitriptyline trial findings. Conclusions Replicating headache frequency trajectories across clinical trials provides strong evidence that youth can improve quickly. Given no effect for medication, we need to better understand what drives this clinically meaningful improvement. Results also suggest an expected trajectory of treatment response for use in designing and determining endpoints for future clinical trials. Trial Registration. ClinicalTrials.gov Identifier: NCT01581281


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