Migraine-Specific Quality Of Life Research Articles

A real-world prospective observational study of eptinezumab in Asian patients with migraine.

To evaluate the real-world effectiveness of eptinezumab for migraine prevention in Asian patients. Eptinezumab is a monoclonal antibody that targets calcitonin gene-related peptide (CGRP), a potent vasodilator with an important role in migraine pathophysiology. Although there is robust clinical evidence from pivotal Phase 3 placebo-controlled trials of the efficacy of eptinezumab for migraine prevention, there are limited data on the real-world effectiveness of eptinezumab in Asian patient cohorts. This was a non-interventional, prospective, multisite cohort study of adults with migraine (International Classification of Headache Disorders, 3rd edition criteria) in Singapore who were prescribed eptinezumab (100 mg at baseline and Month 3, administered intravenously) and were followed until Month 6. The primary endpoint was change from baseline in monthly migraine days (MMDs) at Month 3 and Month 6. Secondary endpoints were ≥30% and ≥50% responder rates, and change from baseline in the Headache Impact Test-6 (HIT-6), Migraine Disability Assessment (MIDAS), Migraine-Specific Quality of Life (MSQ), patient-identified most bothersome symptom (PI-MBS), acute medication use at Month 3 and Month 6, and safety. Enrolled patients (completed = 29/30) had on average 3.4 (SD 2.9) previous preventive treatments; 29/30 of the patients had trialed at least one previous preventive treatment without benefit. Most had previously trialed oral preventives (87%, 26/30) and anti-CGRP (70%, 21/30). Relative to baseline, mean MMDs decreased by 4.3 days (95% CI 2.1-6.4; p < 0.001) at Month 3 and 4.9 days (95% CI 2.1-7.7; p < 0.001) at Month 6. At Month 3 and Month 6, 14/30 (47%) and 15/29 (52%) of the patients were ≥30% responders, and 6/30 (20%) and 8/29 (28%) patients were ≥50% responders, respectively. The number of patients with severe life impairment based on the HIT-6 score (total score 60-78) decreased from 24/30 (80%) at baseline to 19/30 (63%) at Month 3 and 19/29 (66%) at Month 6. The mean MIDAS score decreased by 24.6 points (95% CI 2.82-46.38; p = 0.028) at Month 6, and the mean MSQ score increased by 12.2 points (95% CI 5.18-19.20; p = 0.001) at Month 3 and 13.6 points (95% CI 4.58-22.66; p = 0.004) at Month 6. Most patients reported improvement in the PI-MBS at Month 3 (73%, 22/30) and Month 6 (55%, 16/29). Acute medication use for headache relief decreased by 3.3 days/month (95% CI 1.0-5.6; p = 0.007) at Month 3 and 4.7 days/month (95% CI 1.7-7.7; p = 0.003) at Month 6. Treatment-emergent adverse events (TEAEs) were reported in 16/30 (54%) patients, mostly mild/moderate in severity. No serious TEAEs led to treatment discontinuation. Quarterly eptinezumab administration was effective and well-tolerated in Asian patients with chronic migraine.

Characteristics of patients who seek medical attention for headache and those who do not: cross-sectional survey and linked medical claims data analysis in Japan

ObjectiveTo describe the characteristics of patients who sought medical attention for headache and those who did not.DesignThis observational study used a cross-sectional online survey and linked medical claims data.SettingData from...

SEMG Biofeedback for Episodic Migraines: A Pilot Randomized Clinical Trial.

The aim of this study was to assess the feasibility and potential effectiveness of a 6-week virtual sEMG biofeedback intervention for patients with episodic migraines.Patients with episodic migraines were randomized to treatment with a novel surface EMG (sEMG) at-home biofeedback device or a treatment as usual control group; they completed validated baseline and post-intervention assessments of migraine related disability (migraine-specific quality of life, anxiety and depression). Participants also underwent a series of Quantitative Sensory Testing (QST) procedures referring to several different tests that quantitatively assess responses to mechanical stimuli during two separate visits (baseline and post intervention).No adverse events were reported during the study. Compared to the treatment as usual comparison group, patients in the sEMG biofeedback group reported lower migraine disability (p < 0.05). Compared to baseline, participants in the sEMG biofeedback group demonstrated statistically significant reductions in anxiety (p < 0.01), and significant increases in quality of life (p < 0.001), and significant decreases in temporal summation (p < 0.05) assessed by QST. No significant changes were observed in any of the outcomes in the control comparison group (p > 0.05). No significant changes were observed in migraine frequency in either of the two groups (p > 0.05). In addition, mediation analyses revealed that changes in migraine related quality of life mediated group effects on changes in migraine disability.Virtual sEMG biofeedback shows promise as a potential therapy for reducing disability, anxiety and depression and improving quality of life in individuals with episodic migraines. These results demonstrate the feasibility of a digital intervention for migraines and set the basis for conducting a future, larger scale randomized controlled trial to confirm these preliminary findings.

Comparison of Efficacy of Botulinum Toxin Injection and Conventional Oral Drugs for Treatment of Refractory Migraine

Background: Background: Migraine, a debilitating neurological condition, significantly impacts quality of life. Despite various treatments, some cases remain refractory to conventional therapies. This study explores the efficacy of Botulinum Toxin Type A (BOTOX) injections compared to Conventional Oral Drugs (CODs) in treating refractory migraines, offering potential advancements in migraine management. Objectives: This single-center retrospective cohort study compared the efficacy and safety of Botulinum toxin (BOTOX) injection and Conventional Oral Drugs (COD) for treating the refractory migraine. Methods: Between May and August of 2023, 78 adults with refractory migraine were enrolled at tertiary care center in Islamabad. Their demographic data revealed the mean age of 46.5 years (SD=10.09), gender distribution of 28 males (35.90%) and 50 females (64.10%), and distribution of 27 employed (34.61%) and 51 unemployed (65.30%). Results: Average duration of refractory migraines was 9.72 years and average number of migraines per month was 22. The number of headache days per month decreased from 22 at baseline to 19 after two months and to 12 after three months (p=0.239) as the primary outcome measure (p&gt;0.05). The VAS scores decreased substantially from 7.6 to 5.5 (p=0.049), indicating decrease in headache severity (p&lt;0.05). Scores on Migraine-Specific Quality of Life (MSQ) increased from 43 to 73% (p&gt;0.05). The Migraine Disability Assessment (MIDAS) scores decreased from 66 to 48 (p=0.047) and Headache Impact Test (HIT-6) scores decreased from 69 to 40 (p=0.025), indicating an improvement in disability and quality of life (p&lt;0.05). Injection site pain (n=35), nausea (n=25), dizziness (n=15), fatigue (n=12), parched mouth (n=5), and muscle weakness (n=5) were reported as adverse effects. Conclusion: While BOTOX treatment significantly improved measures of headache severity, disability, and quality of life, patient tolerability and potential distress must be considered when selecting this treatment.

Effect of fremanezumab on migraine-specific quality of life in Korean patients with chronic and episodic migraine

Effect of fremanezumab on migraine-specific quality of life in Korean patients with chronic and episodic migraine

Exploring the effects of resveratrol supplementation on cerebrovascular function in hormonal migraineurs: A pilot study

BackgroundPast research suggests that hormonal migraineurs may have poorer cerebrovascular function than women who do not suffer from migraine. Resveratrol, a vasoactive phytoestrogen, has been shown to improve cerebrovascular function in several populations but has never been tested in hormonal migraineurs. AimTo investigate the effects of 3-month resveratrol supplementation on the cerebrovascular function of hormonal migraineurs. MethodsWe conducted a randomised, double-blind, placebo-controlled, crossover intervention pilot study with resveratrol (150 mg/d for 3 months) in ten hormonal migraineurs (mean age: 37.2 ± 2.6 years). Participants visited the University of Newcastle’s Clinical Nutrition Research Centre where quality of life and disability, and cerebrovascular function were assessed. Quality of life and disability were examined using Migraine-Specific Quality of Life, Headache Impact Test-6 and the Migraine Disability Assessment. Cerebrovascular function was determined using transcranial Doppler ultrasound to bilaterally measure blood flow velocity in the middle and posterior cerebral arteries at rest and in response to a hypercapnic stimulus. Cerebrovascular responsiveness to a cognitive task battery was also measured bilaterally in the middle cerebral arteries. ResultsCompared to placebo, blood flow velocity in the right posterior cerebral artery was significantly higher (P = 0.041) following resveratrol supplementation. No other significant differences in cerebrovascular function between resveratrol and placebo treatments were observed. Baseline correlation analyses revealed higher blood flow velocities in the middle and posterior cerebral arteries were associated with better quality of life and less disability. However, higher cerebrovascular responsiveness to hypercapnia in the posterior circulation was associated with higher migraine-related disability and poorer migraine-related quality of life. ConclusionIn this pilot we found evidence that resveratrol may increase blood flow velocity in the right posterior cerebral artery in hormonal migraineurs. Larger cohorts are required confirm this effect and its potential relationship to migraine in premenopausal women.

A Case Report of Craniosacral Therapy and Acupuncture for Chronic Migraine

Objectives: This case report aims to describe the effects of craniosacral therapy and acupuncture in a patient with chronic migraine.Methods: A 33-year-old man with chronic migraine was treated with 20 sessions of craniosacral therapy and acupuncture for 8 weeks. The number of migraine and headache days were monitored every month. The pain intensity of headache was measured on the visual analog scale (VAS). Korean Headache Impact Test-6 (HIT-6) and Migraine Specific Quality of Life (MSQoL) were also used.Results: The number of headache days per month reduced from 28 to 7 after 8 weeks of treatment and to 3 after 3 months of treatment. The pain intensity of headache based on VAS reduced from 7.5 to 3 after 8 weeks and further to &lt; 1 after 3 months of treatment. Furthermore, the patient’s HIT-6 and MSQoL scores improved during the treatment period, which was maintained or further improved at the 3 month follow-up. No side effects were observed during or after the treatment.Conclusion: This case indicates that craniosacral therapy and acupuncture could be effective treatments for chronic migraine. Further studies are required to validate the efficacy of craniosacral therapy for chronic migraine.

Improved quality of life with fremanezumab in Japanese and Korean patients with episodic and chronic migraine: Results of two multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trials.

To evaluate quality of life (QoL) endpoints from two 12-week trials investigating fremanezumab efficacy and safety in Japanese/Korean patients with chronic (CM) or episodic (EM) migraine. Migraine is a leading cause of disability and affects QoL considerably, interfering with work and daily activities, social and family life, and emotional wellbeing. This planned exploratory analysis used data from two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in which Migraine-Specific QoL (MSQoL; Role Function-Restrictive [RR], Role Function-Preventive [RP], and Emotional Function [EF] domains) scores and Patient Global Impression of Change (PGIC) scores were pre-specified QoL outcomes in individuals receiving monthly or quarterly fremanezumab or placebo. In both trials, MSQoL was assessed at baseline, and MSQoL and PGIC at Weeks 4, 8, and 12. PGIC responders had a score of ≥5 points, indicating significant improvement. Mean baseline MSQoL scores were similar across groups in both CM (N = 565; RR, 60.3-61.5; RP, 78.5-80.0; EF, 69.0-71.4) and EM (N = 353; RR, 68.6-71.1; RP, 83.1-85.7; EF, 76.7-81.9) trials. In the CM trial, all three MSQoL domains improved in both fremanezumab groups at 12 weeks compared with placebo: least squares mean (LSM) and standard error (SE) change from baseline, p versus placebo (quarterly; monthly; placebo): RR 14.9 (1.3), p = 0.030; 15.1 (1.4), p = 0.020; 11.6 (1.3); RP 8.9 (1.1), p = 0.007; 8.6 (1.1), p = 0.013; 5.4 (1.1); EF 13.3 (1.5), p < 0.001; 12.5 (1.5), p = 0.003; 7.5 (1.5). In the EM trial, RR/EF domains improved in both fremanezumab groups compared with placebo: LSM change from baseline, p versus placebo (quarterly; monthly; placebo): RR 16.3 (1.4), p = 0.003; 16.4 (1.3), p = 0.002; 11.6 (1.4); EF 13.0 (1.3), p < 0.001; 11.5 (1.2), p = 0.004; 7.4 (1.3); RP improved in the quarterly group RP 8.6 (1.1), p = 0.010; 7.6 (1.1), p = 0.066; 5.4 (1.1). The proportion of PGIC responders at Week 12 was greater in the monthly and quarterly fremanezumab groups compared with the placebo group in the CM (96/182 [52.7%] and 98/180 [54.4%] vs. 68/179 [38.0%]; p < 0.05) and EM trial (81/118 [68.6%] and 86/113 [76.1%] vs. 38/111 [34.2%]; p < 0.001). Patients with EM/CM receiving monthly or quarterly fremanezumab, for a duration of 12 weeks, showed significant improvements in their QoL.

Modeling Monthly Migraine-Day Distributions Using Longitudinal Regression Models and Linking Quality of Life to Inform Cost-Effectiveness Analysis: A Case Study of Fremanezumab in Japanese-Korean Migraine Patients.

As regression approaches have been used more recently to model the effectiveness and health-related quality of life (HRQOL) of novel migraine treatments, an example is provided for fremanezumab. The objective is to estimate the distribution of mean monthly migraine days (MMD) as a continuous variable and corresponding migraine-specific utility values as a function of the MMD, to inform health states in a cost-effectiveness model (CEM). Three longitudinal regression models (zero-adjusted gamma [ZAGA], zero-inflated beta-binomial [ZIBB], and zero-inflated negative binomial [ZINBI]) were fitted to Japanese-Korean clinical trial data of episodic (EM) and chronic migraine (CM) patients treated with fremanezumab or placebo, to estimate MMD over a period of 12 months. The EQ-5D-5L and the migraine-specific quality-of-life (MSQ), mapped to the EQ-5D-3L, questionnaires were used to measure HRQOL. Migraine-specific utility values were estimated as a function of MMD using a linear mixed effects model. The ZIBB models fitted the data best in estimating the distribution of mean MMD over time. MSQ-derived values were more sensitive than the EQ-5D-5L values for the effect of the number of MMD on HRQOL, with higher values for less MMD and more time on treatment. Using longitudinal regression models to estimate MMD distributions and linking utility values as a function is an appropriate method to inform CEMs and capture inter-patient heterogeneity. The observed distribution shifts demonstrated fremanezumab's effect at reducing MMD for both EM and CM patients, while treatment effect on HRQOL was captured by MMD and time on treatment.

0891 Sex-Specific Differences in Polysomnographic Biomarkers of Sleep Disruption and Sleep Disordered Breathing in Migraine

Abstract Introduction The importance of sex as a biological variable on the relationship of migraine and sleep disturbance has not been well-characterized. Given evidence of 1)bidirectional relationships of poor sleep and migraine severity and 2)greater activation of brain regions involved in emotional processing in women compared to men with migraine, we hypothesized that sleep architectural disruption may contribute to sex-specific differences in quality of life measures, particularly those attributed to emotional processing. Methods This was a retrospective cohort study of migraine patients aged &amp;gt;18 years seen in the Cleveland Clinic headache program with polysomnogram data. Migraine burden was measured by the 20-item migraine-specific quality of life(MSQOL) encompassing three domains: emotional function(EF), role function-preventative, and role function-restrictive. Linear regression models were used to assess the association of each MSQOL domain with sleep architectural measures and the statistical interaction with sex was examined. Coefficients and 95% confidence intervals were estimated and compared with adjustment of age, race, body mass index(BMI) and comorbidities. Results Of 245 patients with migraine,37(15.1%) were male. Males had higher AHI (10.0 [5.3, 18.5] vs. 5.7[1.8, 11.4], p=0.006). The difference in MSQOL-EF scores was not statistically significant (males:73.3[53.3,86.7] vs. females:60.0 [33.3,80.0], p= 0.066). There was no statistical difference in percent N2 or REM between sexes, though males had greater %N1, and lower %N3 (10.9[5.9,19.2] vs. 6.6[4.1,11.9],p=0.039). The association of MSQOL-EF with percent of N2 and REM sleep differed by sex. For each 5% increase in N2, there was a 5% reduction of MSQOL-EF 2.08 (-2.08, 95%CI [-6.86,2.70],p=0.39) in females compared to a 6.84 reduction in males (-6.84, 95%CI [-15.9,2.22],p=0.14), p-value for interaction=0.044. For each 5% increase in REM, MSQOL-EF increased 1.26 (1.26, 95%CI [-3.68,6.21],p=0.61) in females, and increased by 6.27 in males (6.27, 95%CI [-3.11,15.6], p=0.19),p-value for interaction=0.044. Conclusion Although males had greater sleep disruption compared to females, there was no significant difference in MSQOL-EF scores. However, sex-specific differences of extent of sleep stage composition and MSQOL-EF were observed suggesting influence of sleep architectural alterations on greater responsivity of migraine emotional processing in men versus women. Future investigation should better characterize longitudinal relationships and underlying neurobiological mechanisms underlying these findings. Support (if any) Association of Migraine Disorders

Long-Term Preventive and Acute Treatment of Migraine With Rimegepant Improves Health Related Quality of Life (P12-12.003)

Long-Term Preventive and Acute Treatment of Migraine With Rimegepant Improves Health Related Quality of Life (P12-12.003)

Effect of aerobic exercises and therapeutic pain neuroscience education on disability, pain, head posture and QOL in migraine patients

Migraine is a type of primary headache with a high degree of associated disability that can present with a variety of indications and co-morbidities. The role of physical therapy treatment in migraine management is largely obscure. To investigate the combine effect of aerobic exercises and therapeutic pain neuroscience education on disability, pain pressure threshold, head posture and quality of life (QoL) in patients having migraine. Subjects were screened by using Migraine Disability Assessment (MIDAS) and after screening total sample of 50 subjects were randomly assigned into two groups: Group A (Experimental, n=25) and Group B (Control, n=25). Migraine disability assessment, pressure algometer, craniovertebral angle (CVA) and migraine specific quality of life were examined before and after 6 weeks of the intervention. Group A were given aerobic exercises and therapeutic pain neuroscience education along with conventional treatment for 45 min 3 days/week for 6 weeks, whereas participants in the Group B performed conventional exercises alone for 20 min 3 days/week for 6 weeks. Significant differences were observed in migraine disability score (P=0.003) and pain pressure threshold (P=0.039, P=0.030 and P=0.025) and improvement in forward head posture (P=0.001) between the groups after the intervention period, signifying greater improvement in the group A. QoL also improved in both the groups after intervention. Main findings of the present study suggest that the therapeutic pain neuroscience education and aerobic exercises combined with conventional treatment together maybe helpful to give better quality of life, reduced disability, increased pain pressure threshold and increased CVA to patients with migraine.

A Cross Sectional Observational Study to Assess Clinical Characteristics, Prescription Pattern and Health Related Quality of Life in Migraine Patients at Tertiary Care Teaching Hospital

Published on:August 2022Journal of Young Pharmacists, 2022; 14(3):314-321Original Article | doi:10.5530/jyp.2022.14.62 Authors: Rajesh Hadia1, Vidhi Kapadi1, Kushal Parekh1, Sunetra Naidu1, Sanjay Prakash2, Vikas Chandrakar1, Hemraj Singh Rajput1 1Department of Pharmacy Practice, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, INDIA. 2Department of Neurology, SBKS Medical Institute and Research Centre, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, INDIA. Abstract: Objectives: The present study was focused on assessing the clinical characteristics which include the symptom profile, triggering factors, prescription pattern, headache-related disability, and its impact on patients’ HRQoL. Methods: A cross-sectional observational study was conducted from October 2019 to March 2020 at the Department of Neurology, Dhiraj General Hospital-Vadodara. The data was collected from the prescription prescribed by the respective neurologist and by filling a pre designed questionnaire. All patients who met the inclusion criteria enrolled in a study. Results: In this study, the incidence of migraine is higher in females (78%), than males (23%). The majority of patients were having a severe disability and severe impact on HRQoL with high MIDAS (Migraine Disability Assessment Scale) and HIT-6 (Headache Impact Test-6) scores in opposing MSQoL v2.1 [Migraine Specific Quality of Life (Version 2.1)] where the majority of patients gained less score showing poor quality of life. A higher MIDAS score was observed in chronic migraineurs than episodic migraineurs (32.42 ±18.65 and 30.15 ±18.93) while HIT-6 showed a comparable score (63.98 ±6 and 63.38 ±6.29). Unlike MIDAS and HIT-6, MSQoL v2.1 showed less scores in chronic migraineurs than episodic migraineurs (45.66 ±22.59 and 48.82 ±23.77) which depicts that chronic migraineurs had a poor health-related quality of life than the episodic migraineurs. Conclusion: To conclude, healthcare professionals routinely evaluate the quality of life and related disability to determine whether patients are receiving effective treatment and whether any additional treatment strategies are warranted to enhance QOL.Keywords: Migraine, Health-related quality of life, MIDAS, HIT-6, MSQoL v2.1.

Effect of herbal medicine (Jodeungsan) on migraine: A double-blind randomized clinical trial

BackgroundMigraine is a relatively common disease that has a significant effect on the daily activities of affected individuals. The purpose of this study was to explore the effects of herbal medicine (Jodeungsan, JDS) on migraine. MethodsSixty-four patients with migraine were recruited and randomized to either the JDS or placebo group at a 1:1 ratio. The subjects received JDS or placebo daily for four weeks. The primary outcome was a change in the number of headache attack days (HADs), and the secondary outcome measures were the headache impact test (HIT), migraine-specific quality of life (MSQoL), the deficiency and excess pattern identification questionnaire (DEPIQ), the cold and heat pattern identification questionnaire (CHPIQ), and the blood stasis pattern questionnaire (BSPQ). ResultsIn all, 61 of the 64 patients took the investigational drugs for four weeks. The number of HADs did not significantly differ between the JDS and placebo groups at the end of the study. However, the HIT and MSQoL results showed significant improvement over the baseline in both groups. ConclusionsJDS did not have a significant effect on chronic migraine. Larger studies are needed to confirm this result. Trial registrationClinical Research Information Service (https://cris.nih.go.kr/): KCT0003121.

Bariatric Surgery in Migraine patients: CGRP Level and Weight Loss.

Obesity makes migraine more prevalent and severe. Serum level of calcitonin gene-related peptide (CGRP) is associated with the severity of migraine attacks. Although the effect of weight and bariatric surgery has been studied on migraine, the role of CGRP in migraine remission after weight loss surgery needs more investigation. Patients with severe obesity who were bariatric surgery candidates and had been diagnosed with chronic migraine were included in this study. Weight, BMI, number of days with headache in the past 3months, and severity of headaches in 10-point Likert VAS, Migraine Disability Assessment Scale (MIDAS) and Migraine Specific Quality of life (MSQ) questionnaire scores, and serum CGRP levels were evaluated before and within 6-10months after surgery. Sixty patients with chronic migraine with severe obesity were included. Ninety-five percent of patients reported a significantly lower number of attacks (21 to 8, p < 0.001) and severity of headaches within 90-day (7.7 to 4.8, p < 0.001); MIDAS (64.4 to 25.5, p < 0.001) and MSQ scores (44.6 to 26.8, p < 0.001) and CGRP level (252.7 to 130.1, p < 0.001) were significantly reduced after surgery with a mean follow-up of 7.5months. Changes in MIDAS, MSQ, and CGRP were significantly associated with weight-related variables. Bariatric surgery decreases the frequency of migraine attacks, lessens the severity of headaches, and improves the quality of life and disability as well as CGRP plasma levels, suggesting CGRP as a possible etiology in the migraine-obesity link.

Acupuncture Based on Regulating Autonomic Nerves for the Prevention of Migraine Without Aura: A Prospective, Double-Dummy, Randomized Controlled Clinical Trial.

BackgroundMigraine without aura (MWoA) is a nervous system disease, which is closely related to autonomic nerves dysfunction. As a popular non-pharmacological alternative treatment for preventing migraine, it remains unclear whether the acupuncture can prevent MWoA. Thus, this trial aims to evaluate the preventive effect and safety of the acupuncture method of stimulating acupoints that regulate autonomic nerves in MWoA patients.MethodsThis is a single-center, prospective, double-dummy, randomized controlled clinical trial. A total of ninety-six patients with MWoA are randomly allocated to acupuncture combined with the placebo group and sham acupuncture combined with the medication group in a 1:1 ratio. All subjects will receive intervention for 8 weeks and follow-up assessments three times (one month, three months, and six months in follow-up visiting). The frequency of acupuncture in both groups is three times a week for eight weeks. The primary outcome will be evaluated using a visual analog scale (VAS) and the number of migraine attacks per four weeks. The secondary outcome measures will include the migraine-specific quality of life (MSQOL) scale and headache needs assessment survey (HANA) questionnaire scale.ResultsThe acupoint selection of this clinical trial is based on the combination of traditional Chinese medicine theory with modern medicine, thereby evaluating the efficacy and safety of the acupuncture method of stimulating acupoints that regulate autonomic nerves in the prevention of MWoA. The results may provide evidence of the beneficial effects of acupuncture on the prevention of MWoA by regulating autonomic nerves dysfunction.Trial RegistrationClinicalTrials.gov NCT04766762.

P.015 Monthly migraine days, acute medication use-days, and migraine-specific quality of life in responders to atogepant: a post hoc analysis

Background: In phase 3 ADVANCE, atogepant 60mg reduced mean monthly migraine days (MMDs) from 7.8 days (baseline) to 3.0 (weeks 9-12; Δ=−4.7) in the overall episodic migraine population [treatment responders and nonresponders (i.e., marked benefit and minimal benefit)], which obscures information regarding magnitude of treatment effect in these populations. Here, magnitude of treatment effect in atogepant responders and nonresponders is characterized. Methods: Mean MMDs, acute medication use-days (MUDs), and Migraine-Specific Quality of Life-Role Function-Restrictive (MSQ-RFR) scores were calculated in treatment responders (based on MMD percentage reduction) and nonresponders from ADVANCE participants. Results: From baseline to weeks 9-12, ≥50% improvement was achieved by 71% (139/195) of participants. In these responders, MMDs reduced from 7.6 to 1.3 (Δ=−6.3). 50% (97/195) of participants achieved ≥75% response. In this group, MMDs reduced from 7.7 to 0.6 (Δ=−7.1). Atogepant 60mg nonresponders (&lt;25% reduction in MMDs; 15% [30/195 participants]) showed MMD change from 7.7 to 9.1 (Δ=+1.4). Acute MUDs in ≥50% MMD responders decreased 7.1 to 1.6 (Δ=−5.5). In treatment-nonresponders, acute MUDs were 7.3 (baseline) and 7.2 (weeks 9-12; Δ=−0.1). Similar mean MSQ-RFR score changes were observed in both populations. Conclusions: Of participants who experienced ≥50% reduction in MMDs, 71% had substantial treatment effect (ΔMMD=−6.3), representing 83% reduction in MMDs.

P.021 Evaluation of PREEMPT fixed-dose, fixed-site and follow the pain treatment paradigms in the PREDICT Study

Background: Phase 3 PREEMPT established safety and efficacy of 155-195U onabotulinumtoxinA in adults with chronic migraine (CM). This analysis of the PREDICT study (NCT02502123) evaluates real-world effectiveness and safety of 155U, 156-195U and 195U-onabotulinumtoxinA in CM. Methods: Patients received onabotulinumtoxinA approximately every 12-weeks (≤7 treatment cycles [Tx]) per Canadian product monograph). Primary endpoint was mean change from baseline in Migraine-Specific Quality of Life (MSQ) at Tx4. Headache days, physician and patient satisfaction were evaluated. Analysis stratified safety population (≥1 onabotulinumtoxin A dose) into 3 groups (155U,156-195U,195U) by dose received on ≥3 of the first 4 Tx. Results: 184 patients received ≥1 onabotulinumtoxin A dose (155U, n=68; 156-195U, n=156; 195U, n=13 on ≥3 Tx). Headache days decreased over time compared to baseline (Tx4: -7.1[6.7] 155U; -6.5[6.7] 156-195U; -11.2[6.4] 195U). Physicians rated most patients as improved, and majority of patients were satisfied at final visit (80.8% 155U; 83.6% 156-195U; 90% 195U). Treatment-emergent adverse events (TEAEs) were reported in 18/68(26.5%) patients in 155U-group, 41/65(63.1%) in 156-195U-group and 10/13(76.9%) in 195U-group; treatment-related TEAEs were 9(13.2%), 10(15.4%) and 3(23.1%) respectively; serious TEAEs were 0, 3(4.6%) and 1(7.7%), none treatment-related. Conclusions: Long-term treatment with 155U, 156-195U, and 195U-onabotulinumtoxinA in PREDICT was safe and effective CM treatment. No new safety signals were identified.

Monthly Migraine Days, Acute Medication Use Days, and Migraine-Specific Quality of Life in Responders to Atogepant: A Post Hoc Analysis (S31.008)

Monthly Migraine Days, Acute Medication Use Days, and Migraine-Specific Quality of Life in Responders to Atogepant: A Post Hoc Analysis (S31.008)

Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant \u2013 post hoc results from an open label safety study (BHV3000\u2013201)

BackgroundThe objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks.MethodsEligible subjects were adults with ≥1 year history of migraine and ≥ 6 MMD at baseline, who used rimegepant 75 mg up to once daily PRN (at their discretion) for up to 52-weeks in an open-label safety study (BHV3000–201; NCT03266588). Mean MMD were calculated at each 4-week period, along with mean monthly tablets taken. Migraine-specific quality of life (MSQv2) data were mapped to EQ-5D utilities and used to characterize HRQoL over time. A published network meta-analysis was used to characterize pain hours as well as time periods spent migraine free.ResultsOne thousand forty four subjects were included in this post-hoc analysis. Overall mean MMD were 10.9 at baseline and decreased to 8.9 by week 52. Tablet use remained stable over the follow-up period. A total of 0.08 incremental QALYs were associated with rimegepant use.ConclusionFor subjects with 6 or more MMD, acute treatment of migraine attacks with rimegepant 75 mg on a PRN basis over one-year of follow-up was found to be associated with reduced MMD frequency without an increase in monthly tablet utilization, and improved HRQoL. There was no evidence of medication-related increases in MMDs when rimegepant 75 mg was used as needed for the acute treatment of migraine over 52-weeks.Trial registrationClinicalTrials.gov identifier NCT03266588.