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18th European Headache Congress

Chair

Professor

Prof. Dr.

Establishing relationships between efficacy, tolerability and the serum concentration of candesartan when used as migraine prophylaxis

New clinical developments in prophylactic and acute medications

What are the relationships between efficacy, tolerability and the serum concentration of candesartan when used as migraine prophylaxis?A Norwegian prospective observational study on migraine patients initiating per oral prophylactic treatment. Participants had first a 4-week baseline period prior to treatment initiation and then a 12-week follow-up period with telephone consultations and serum concentration measurements every four weeks. Daily headache diary registration through smartphone application. Side effect information was collected in every telephone consultation and in case of patient inquiries. Analysis was prespecified in a SAP. Mixed logistic regression model was used to estimate efficacy and multilevel mixed logistic regression model was used for the relationship between serum concentration and efficacy.167 (of the total study population of 256) initiated candesartan. Of participants initiating candesartan, 89% were female and 54% had chronic migraine. 20% had medication overuse headache. Candesartan led to a reduction of 2,4 moderate-severe headache days from baseline to week 9-12 (p=0.000). We also found that for every 10th unit increase of candesartan serum concentration, the odds of having a headache day were 0.97 (p=0.002). The average number of related side effects was 1,3 with orthostatic dizziness as the most common one. Most side effects (86%) were graded mild. Analysis on side effect and serum concentration relationships is currently ongoing.Candesartan is well tolerated and efficacious in a real word setting. Increase in candesartan serum concentration does very slightly reduce the odds of having a headache day.

ePoster

Vaporized Cannabis versus placebo for acute migraine – a randomized controlled trial

To test the efficacy of cannabis for acute migraine in a randomized, double-blind, placebo-controlled, crossover trial.In this randomized, double-blind, placebo-controlled, crossover trial, adults with migraine treated up to 4 separate migraine attacks, 1 each with 4 different treatments. The 4 treatments were 1) 6% THC; 2) 11% CBD; 3) 6% THC/11% CBD mix; and 4) Placebo flower from the NIDA Drug Supply Program. They were vaporized in a randomized order, with ≥1 week washout between treatments. The primary endpoint was pain relief at 2 hours from vaporization. Secondary endpoints were pain freedom and most bothersome symptom (MBS) freedom at 2 hours from vaporization.92 participants were enrolled and randomized and 71 participants treated at least one migraine attack. Mean age was 41 and 82.6% were female. Participants entered 2-hour data for 234 attacks. THC/CBD mix was superior to placebo at achieving pain relief (67.2% vs 46.6%, p=0.016), pain freedom (34.5% vs. 15.5%, p=0.017) and MBS freedom (60.3% vs. 34.5%, p=0.005) at 2 hours, sustained pain freedom at 24 hours, and sustained MBS freedom at 24 and 48 hours. THC only was superior to placebo at achieving pain relief (68.9% vs. 46.6%, p=0.008), but not pain freedom or MBS freedom at 2 hours. CBD only was not superior to placebo for any outcomes at 2 hours. There were no serious adverse events.Acute migraine treatment with vaporized cannabis flower containing 6% THC/11% CBD was efficacious at 2 hours post-treatment with sustained pain freedom at 24 hours and sustained MBS freedom at 24 and 48 hours.

Role of SphenoCath procedure in the treatment of migraine – a retrospective study

Sphenopalatine ganglion (SPG) block has been used by clinicians in the treatment of headache disorders. The sensory and autonomic fibers that travel through the SPG provided the rationale for symptoms associated with these syndromes. SphenoCath® is a catheter device that block SPG with a common local anesthetic (Lidocaine). In literature, there are no randomised controlled trials about the use of SphenoCath® device for SPG blockade in treatment and prevention of migraine. The object of this study is to assess the effectiveness of SPG block by Sphenocath® in a migraine population.We retrospectively enrolled patients affected by high frequency episodic or chronic migraine with or without medication overuse, according to the criteria of the International Classification of Headache Disorders, 3rd edition. We assessed changes in Migraine Disability Assessment Questionnaire (MIDAS), Numeric Pain Rating Scale (NPRS), Monthly Migraine Days (MMDs) and Monthly Acute Migraine Medications (MAMMs). The questionnaires were performed at baseline and one, three, six, and twelve months after SphenoCath® treatment.A total of 76 participants were screened and 30 were included. A significant reduction of MIDAS (p<0,001), NPRS (p<0,001), MMDs (p<0,001), and MAMMs (p<0,001) was detected, mostly after one and three months of treatment, but also after six months for MMDs (p=0,039), NPRS (p=0,011), and monthly triptan medications (p=0,018). At one-year follow-up, a slightly significant decrement of NPRS (p=0,039), and monthly triptan medications (p=0,043) was observed. Half of patients reached a 50% reduction in MAMMs and 40% of subjects reported 50% reduction in MMDs at 1 month follow-up. There were 17 non severe adverse events, mostly local discomfort.Trans-nasal SPG blockade using Sphenocath® is an emerging, effective and safe option for the treatment of disabling migraine. Prospective studies are needed to further confirm these findings.

Prof.

Use of Rimegepant 75 mg for the acute treatment of migraine is associated with a reduction in monthly migraine days – a pooled analysis of 2 open-label trials

Rimegepant, a calcitonin gene-related peptide receptor antagonist, is indicated for acute and preventive treatment of migraine in adults. This analysis examined whether long-term use of rimegepant for acute treatment of migraine may provide an additional preventive effect.Data were pooled from 2 uncontrolled long-term open-label trials of rimegepant (NCT03266588, NCT05371652). Participants in this analysis had ≥6 monthly migraine days (MMDs) during a 30-day observation period (OP). Participants took oral rimegepant 75 mg as needed, up to once per day for up to 52 weeks, for acute treatment of migraine attacks of any severity. Adverse events (AEs) and change in the number of MMDs (relative to the OP) were summarized descriptively.Of 1288 treated participants, 68.7% reported an AE, 4.7% reported a severe AE, 2.9% reported a serious AE, and 2.4% reported an AE leading to rimegepant discontinuation. Upper respiratory tract infection (9.5%), nasopharyngitis (7.8%), and COVID-19 (7.6%) were reported by ≥5% of participants. Among 1269 participants included in the MMD analysis, the mean (SD) number of MMDs during the OP was 11.1 (4.3). The number of MMDs decreased, relative to the OP, over the course of 52-week treatment with rimegepant (Table). The mean (SD) change in MMDs was –2.0 (4.6) for the overall 52-week treatment period.Long-term use of rimegepant 75 mg for acute treatment of migraine, up to once per day for up to 52 weeks, was well tolerated and may provide an additional preventive effect as evidenced in a reduction in MMDs. The observation that MMDs were reduced over time suggests that medication overuse headache is unlikely to be associated with rimegepant.

A multidisciplinary multicentric approach to the identification of BIOmarkers of MIGraine (BIOMIGA project): an open-label, prospective clinical study based on the stratification of responders to Erenumab

In this multicenter prospective study, we aim to identify multimodal biomarkers predicting response to CGRP monoclonal antibodies in subjects with migraine.Clinical, molecular and radiological data were collected in three headache centers: IRCCS Mondino Foundation (Italy), Vall d"Hebron University Hospital (Spain), and University of Hamburg (Germany).Participants were deeply phenotyped at baseline before 3-month treatment with erenumab (prescribed according to local reimbursement guidelines if ≥8 headache/days/months (MHD)), and classified as responders if a reduction ≥ 50% headadche/days in the last month of treatment was achieved.Here we present the differences in the clinical variables between groups.164 participants were included, 137 (83.5%) female, median age 42 years , 62/164 (38 %) had a diagnosis of chronic migraine (CM), and 102/164 (62%) had high-frequent episodic migraine (EM). The median MHD at baseline was 13 [8-25 95% non-parametric C.I] . In the third month of treatment, 76/164 (48.%) were "responders" with a mean of 4 [1-8] MHDs; whilst non-responders had 11 (6-25) MHD. CM was more prevalent among non-responders (p=0.024).No differences were detected between females and males in MHDs reduction after 3 months, although females showed a significant reduction in MIDAS score (p=0.038) and a significant higher Beck Anxiety Inventory (p=0.004) and Mig-SCog scores (p<0.001).Before treatment, females had higher scores on the Mig-SCog (p=0.041) and MIDAS scales (p=0.043).At a clinical level there are no significant differences between responders and non-responders after 3 months of erenumab treatment. However, less headache days/month at baseline were correlated with higher responder rates; and females had higher disability scores at baseline. This cohort is similar to other ones described.Acknowledgment: This study was funded by ERANet Neuron under the project code BIOMIGA. The funding source did not influence the way the study was conducted

Rimegepant effectiveness and tolerability as acute migraine treatment (GAINER) – a real-world multicentric study

Rimegepant has been recently approved for the acute migraine treatment. While its efficacy has been proven in clinical trials, real-world data are currently lacking. Thus, we designed a prospective multicentric study to evaluate rimegepant effectiveness and tolerability in the real-world setting (NCT05903027).We enrolled 87 patients (76% females, 44.3+11.7 years, 28% with chronic migraine, baseline monthly migraine days 9.4+7.8) from 13 Italian headache centers. Patients were instructed to treat up to four migraine attacks with rimegepant 75 mg. Using an ad hoc diary, we prospectively collected migraine-attack features every 30 minutes after rimegepant administration, up to 2 hours (2h).Preliminary analyses were conducted on 43 reported first-treated attacks (8/43 in CM patients), and on 91 total attacks. At rimegepant intake, 38.5% of patients rated migraine intensity as severe (3 on a 0-3 rating scale). Pain freedom 2h post-dose was reported in 58.1% (25/43) of first-treated attacks, and in 53.8% (49/91) of total attacks. The 2h pain freedom response was not influenced by timing of rimegepant intake (p=0.204), baseline pain severity (p=0.171) and the diagnosis of chronic/episodic migraine (p=0.626). Freedom from the most bothersome symptom 2h post-dose was reported in 60.4% of attacks. Mild adverse events were reported in 18% total attacks (8/91), namely gastrointestinal discomforts (n=4), fatigue (n=2), dizziness (n=1) and somnolence (n=2). Tolerability was rated as good-to-excellent in 92.3% cases (84/91).Our real-world data support rimegepant effectiveness, safety, and tolerability as acute migraine treatment. In the preliminary analysis, rimegepant effectiveness was not influenced by pain severity and timing of drug intake.

Real-world experience of Lasmiditan for the acute treatment of migraine – a single clinic-based prospective study

We aimed to report the response rate, side effects, and predictors of response and side effects from lasmiditan treatment in Korean patients with migraine.We prospectively recruited patients who received lasmiditan at Seoul National University Hospital from April 2023 to March 2024. Patients' demographics, headache-specific variables, and previous treatment experience were collected at Visit1. We collected the treatment response and side effect profile. Maintenance, dose adjustment, and discontinuation were collected at Visit2, and we defined the tolerability as maintenance or dose increment. The univariable and multivariable logistic regression analysis was performed to identify predictors measured at Visit2.154 patients were included in our study. At Visit1, 110(71.4%) and 44(28.6%) patients were prescribed lasmiditan 50mg and 100mg, respectively. At Visit2, treatment response was observed in 49(44.5%) patients receiving 50mg and 20(45.5%) patients receiving 100mg. 75(48.7%) patients reported side effects. Dizziness(N=45, 60.0%), somnolence(N=15, 20.0%), and nausea(N=13, 17.3%) were the most common side effects. The multivariable logistic model showed that female sex(HR 4.51, 95% CI 1.43–14.19, p=0.01) and higher dose(100mg vs. 50mg; HR 2.35, 95% CI 1.14–4.83, p=0.02) were independently associated with side effects. Lasmiditan dosage was adjusted as follows: dose escalation in 56(36.4%), dose reduction in 17(11.0%), and treatment discontinuation in 40(26.0%) patients. The remaining 41(26.6%) subjects maintained their initial dosage. Lasmiditan was well tolerated in 63.0%(97/154) of patients.This is the first real-world data of lasmiditan response and side effects in Korean patients with migraine. Although used as low dose, lasmiditan was effective in approximately a half of patients in our study regardless of their demographics and headache characteristics. Dizziness was the most common side effects with a higher rate than that reported in clinical trials.

Conditioned pain modulation is associated with the prognosis in patients with migraine

Conditioned pain modulation (CPM) measures the capacity for endogenous analgesia, which is known to decrease in individuals with acute or chronic pain, including patients with migraine. In this study, we aimed to investigate whether CPM capacity is associated with the prognosis in patients with migraine.Patients with migraine were identified by headache specialists according to ICHD-3 criteria and were instructed to maintain a headache diary throughout the study. Responders (R) were defined as participants who showed a reduction of ≧50% monthly migraine day (MMD) by the third month compared to baseline. All participants underwent cold pressor tests (CPT) before starting routine treatment. During CPT, pressure pain thresholds (PPTs) were assessed on the left thenar eminence before and immediately after the immersion of 4±2℃ water of the right hand and forearm as long as the participants could bear or with a time limit of 4 minutes. The CPM capacity was defined as the increase in PPT after CPT. Only participants who finished CPT during the ictal phase were included in analyses to avoid phase-related interference. Independent t-tests or Chi-squared tests were used to identify the differences between R and non-responders (nR).Eighty-seven patients with migraine were prospectively included (71 females, 36.0±10.2 yrs., 7.1±6.6 MMD), and 48 were identified as R by the third month. R (6.9±5.2 vs. 1.3±1.5 days, pThe capacity of intrinsic pain modulation, as assessed by CPT, is associated with the prognosis of patients with migraine.

Assoc. Prof.

Patients satisfaction to triptans and to available oral and injectable medications (OnabotulinumtoxinA/anti-CGRP MAbs) for migraine prophylaxis. Results of a web-based survey

The Greek Society of Migraine and Headache Patients conducted a web-based survey in 2023 to ascertain the patients" satisfaction with conventional and novel migraine therapies.The sampling process was based on a random call to participants to reply to a specific migraine-focused self-administered questionnaire, including 83 questions in Greek, which was distributed nationwide through the online research software SurveyMonkey.We eventually enrolled 2565 patients, the majority of which were females. Our findings clearly demonstrate that migraine is still a burdensome condition. Triptans seem to be partly effective as acute therapies. OnabotulinumtoxinA seems to be effective for almost half of chronic migraine patients (43.9%) to report adequate satisfaction with this treatment (27.8% were "fairly happy", 10.6% were "very happy", and 5.5% were "extremely happy"). Due to their high rates of preventative effectiveness, most respondents treated with anti-CGRP Mabs expressed their optimism concerning their future while living with their migraine (88.25%), as well as towards further improvements in their quality of life (82.8%) status, mostly with fremanezumab.The patients recognize the usefulness of anti-CGRP Mabs in migraine prevention. Considering the market change that is anticipated with the use of gepants and ditans, larger longitudinal population-based studies are warranted to further explore if the new era of migraine therapeutics might further lessen the burden of the disease.

Migraine patients treating with remote electrical neuromodulation (REN) shows significant and clinically meaningful benefits and utilization in a Coverage with evidence development (CED) study

The Remote Electrical Neuromodulation (REN) wearable device (Nerivio) is FDA-cleared and CE-marked non-invasive drug-free option for acute and preventive treatment of migraine in patients aged ≥12 years. REN was shown to be efficacious and safe in multiple trials and real-world studies. Highmark Inc. (Highmark) conducted a CED study to evaluate REN migraine treatment in real-world clinical setting, and to assess the medical necessity of coveraging REN as a standard-of-care therapy.Highmark commercial members diagnosed with migraine were prescribed REN per clinical judgement of their provider and used it for ≥ 3 months. Efficacy was evaluated by the Migraine Disability Assessment (MIDAS) test at baseline and after at least 3 months of use, and by prospective pain and disability reports per treatment. Safety was monitored via adverse event reports.381 patients participated (mean age 40.5, SD=13.2; 91.1% female). Average MIDAS score decreased from 58.3 (SD=59.0) to 46.2 (SD=44.1) after ≥3 months, a statistically significant reduction of 12.1 points (SD=51.8; n=116; p=0.014). 77.8% of patients reported pain relief and 33.3% reported pain freedom 2 hours post-treatment in ≥50% of their treatments. Relief from functional disability was reported by 70.6% of patients, and freedom from disability by 50.0%. Satisfaction, effectiveness and tolerability were reported by 74.2%, 78.1%, and 93.8%, respectively. Three patients reported minor adverse events. The average number of REN devices used per patient per year, extrapolated over all patients for one year, was 4.0 (SD=3.1).Results demonstrate significant improvement in migraine-related disability, pain, and functional impairment in real-world setting. Following this study, REN was added as a standard treatment for migraine under Highmark policy. Members of other health plans worldwide can benefit from similar coverage decisions.

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