Headache最新文献

Objective: We conducted a randomized study to determine if, among emergency department (ED) patients with acute posttraumatic headache, the combination of intravenous (IV) metoclopramide plus dexamethasone would result in less headache intensity during the 48 h after ED discharge than IV metoclopramide plus placebo.

Background: Intravenous metoclopramide can improve acute posttraumatic headache among ED patients, though this benefit is not sustained beyond the ED visit.

Methods: This was a randomized, double-blind, placebo-controlled, parallel group study of IV dexamethasone for acute posttraumatic headache. We enrolled patients who presented to two EDs in the Bronx, NY, with moderate or severe headache that met criteria for acute posttraumatic headache, per the International Classification of Headache Disorders, 3rd edition. All study participants received metoclopramide 10 mg IV. They also were randomized to receive dexamethasone 10 mg IV or placebo (normal saline). The primary outcome was absence of moderate or severe headache within 48 h of ED discharge and no use of analgesic or headache medication within that time. We also report frequency of sustained headache relief. It defined as obtaining and maintaining a headache intensity of mild or none, without the use of rescue medication, for 48 h.

Results: Over a 42-month period commencing in June 2021, 2220 patients were approached for participation and 162 were enrolled. At baseline, slightly more patients in the placebo arm reported severe versus moderate pain. No other baseline differences were noted. After accounting for age, sex, and baseline pain intensity, dexamethasone was not associated with the primary outcome (Adjusted odds ratio 1.11, 95% confidence interval [CI] 0.57, 2.19, p = 0.751). Sustained pain relief was reported by 10/77 (13.0%) of dexamethasone participants and 12/79 (15.2%) of placebo participants (95% CI for difference - 2.2%: -13.1, 8.7%).

Conclusion: Among ED patients with acute moderate or severe posttraumatic headache, one dose of IV dexamethasone did not improve headache outcomes.

Objective: This study evaluated the pharmacokinetics of zavegepant in human breast milk and plasma following a single, 10 mg dose of zavegepant nasal spray.

Background: Zavegepant nasal spray is a member of the gepant class of medications; small molecule inhibitors of the calcitonin gene-related peptide receptor. It is approved in the United States for the acute treatment of migraine with or without aura in adults. However, the transfer of zavegepant to human breast milk in lactating women has not been assessed previously.

Methods: In this Phase 1, open-label, single-arm, single-dose, pharmacokinetic study (NCT06453356), 12 healthy lactating women received a single intranasal dose of 10 mg zavegepant. Blood and breast milk samples were collected over 24 h postdose to assess zavegepant pharmacokinetics. Safety was also assessed. The study was conducted from June 10 to September 26, 2024 at a single-site in the United States.

Results: Geometric mean (geometric percent coefficient of variation [CV%]) milk-to-plasma zavegepant concentration ratios were 0.21 (102%), 0.16 (76%), and 0.04 (130%) for area under the concentration-time curve from time 0 to 24 h postdose, area under the concentration-time curve from time 0 extrapolated to infinity, and maximum concentration, respectively. The geometric mean (geometric CV%) body weight normalized infant dose was 0.05 μg/kg/day (120%) and the geometric mean (geometric CV%) body weight normalized maternal dose was 132.8 μg/kg/day (10%). This resulted in a geometric mean (geometric CV%) relative infant dose of 0.04% (128%). One treatment-emergent adverse event (TEAE; mild dizziness) was reported in one (8%) participant. This TEAE was considered mild in severity. No clinically meaningful abnormalities were observed for vital signs, clinical laboratory testing, and local nasal assessments.

Conclusion: A single intranasal dose of 10 mg zavegepant was generally safe and well tolerated in healthy lactating women and the estimated infant exposure to zavegepant via breast milk is very low.

Objectives/background: This study was undertaken to evaluate patient reasons for nonadoption of migraine-preventive medications. Despite clear recommendations and eligibility criteria for migraine-preventive treatment by the American Headache Society and the availability of these treatments, many people with migraine are not taking appropriate preventive medications. Many are not seeking medical care in the first place, but even among those who are seeking medical care and have a diagnosis of migraine, the uptake of preventive medications remains low.

Methods: The OVERCOME (Observational Survey of the Epidemiology, Treatment, and Care of Migraine) study is an observational, longitudinal web-based survey conducted in more than 60,000 adults with migraine in the United States (US). The current analysis, a secondary post hoc analysis of the 2018-2020 baseline cross-sectional surveys, evaluated medication use in participants. In particular, the analysis investigates why some participants have never taken prescription medication for migraine prevention and examines how this group differs from those who are taking preventive medication, specifically in terms of disease severity and other patient-reported outcomes.

Results: Our findings revealed that among OVERCOME (US) participants who met criteria for migraine (n = 59,001), only approximately half (51.3%) had sought medical care for migraine in the previous 12 months, approximately one third (36.3%) had sought care and received a migraine diagnosis, and only 10% of participants had sought care, received a diagnosis of migraine, and were currently taking prescription medications for migraine prevention. Furthermore, among those who were eligible for migraine-preventive medication based on their headache frequency and associated disability (n = 22,249), 65.3% indicated they had never taken a preventive medication for migraine. The reasons for this were mostly medication-related (25.5% stated they were concerned about side effects, 23.3% said they did not like taking prescription medication, and 20.8% stated that their other medications worked well enough); however, there were also other reasons related to stigma, access, and communication with the health care provider that were noted by participants.

Conclusion: This study highlights an important need for patient education, especially as many of these individuals who had never taken medications to prevent migraine reported experiencing ≥15 monthly headache days (25.3%), severe interictal burden (43.3%), and severe migraine-related disability (53.1%). We believe that these results may be of interest to health care providers who see people with migraine and help them better understand and anticipate their patients' educational needs regarding migraine prevention.

Objective: The aim of this study was to synthesize a unifying disease model for idiopathic intracranial hypertension (IIH) based on the current literature.

Background: IIH is a complex neurological condition defined by abnormally elevated intracranial pressure in the absence of an identifiable etiology. Although various causal mechanisms are thought to contribute to the development of IIH pathophysiology, how they interrelate remains poorly understood.

Methods: Here, we synthesize emerging evidence indicating that cerebrospinal fluid (CSF) and interstitial fluid (ISF) dyshomeostasis drive IIH pathology and how alterations in neurofluid regulation are associated with transverse sinus stenosis, brain volume, and the cerebral glymphatic system.

Results: We propose a unified disease model where obesity-mediated metabolic dysfunction results in impaired glymphatic clearance with consequential accumulation of brain ISF with resultant increased brain volume. This subsequently results in extramural compression of the dural venous sinuses. Dural venous stenosis causes venous hypertension with further veno-glymphatic congestion and a positive feedback loop on impaired glymphatic drainage, which further perpetuates interstitial fluid stasis and increased brain volume with increased intracranial pressure.

Conclusions: The presented unifying disease model integrates various observations and suspected drivers of the condition into a cohesive framework of IIH pathogenesis that may be used for future investigations and clinical conceptualization.

Background: OnabotulinumtoxinA (BoNT-A) is an established preventive treatment for chronic migraine but involves 31 to 40 injections per session, often causing discomfort and post-procedural headaches. Remote electrical neuromodulation (REN) is a noninvasive therapy with efficacy in migraine treatment via conditioned pain modulation but has not been evaluated for procedural pain. This study evaluated REN's effectiveness in reducing acute procedural pain and postprocedural headache associated with BoNT-A injections.

Methods: This was an investigator-initiated single-center, randomized, single-blind, sham-controlled crossover study enrolled 80 adults (aged 22 to 74 years) with chronic migraine undergoing routine BoNT-A treatment. Each participant received one injection session without a device, followed by sessions using active REN and sham in randomized order. REN was applied to the upper arm 10 min prior to injections and removed after injection completion. Pain intensity was measured using a visual analog scale (0 to 100) at pre-procedure, intra-procedure, and post-procedure time points. The primary outcome was procedural pain intensity, and secondary outcomes included post-procedural headache incidence and adverse events. Due to clear benefit, the study was terminated early based on predefined stopping criteria.

Results: Final analysis of 60 participants (mean age 48.0 years; 49/60, 82% female) demonstrated that pre-procedural pain levels were not significantly different between baseline and the active REN or sham (p > 0.999 and p = 0.485, respectively). However, during and after BoNT-A administration, the active REN group reported significantly lower pain scores compared to both the sham and baseline conditions. At intra-procedure, the REN group experienced a mean pain reduction of 15.0 points (p < 0.001), and at post-procedure experienced a 19.1-point reduction (p < 0.001). Sham treatment did not result in significant pain reduction compared to baseline (p > 0.999 for both intra-procedure and post-procedure). Additionally, REN lowered the incidence of headache as an adverse event, with only 15% (8/52) of participants experiencing post-procedural headache compared to 55% (29/53) in the sham group and 39% (23/59) at baseline (odds ratio = 0.28, 95% confidence interval: 0.10 to 0.69, p = 0.008). No additional adverse events were reported.

Conclusions: REN significantly reduces procedural pain and post-procedural headache associated with BoNT-A injections for chronic migraine and may serve as a noninvasive, easily implemented pain management strategy for acute procedural pain. REN represents a promising approach to improving patient comfort during routine migraine treatment as well as reducing post-procedural headache.

Objective: To assess the efficacy of cannabis for the treatment of acute migraine.

Background: Preclinical and retrospective studies suggest cannabinoids may be effective in migraine treatment. However, there have been no randomized clinical trials examining the efficacy of cannabinoids for acute migraine.

Methods: In this randomized, double-blind, placebo-controlled, crossover trial, adults with migraine treated up to four separate migraine attacks, one each with vaporized (1) 6% Δ9-tetrahydrocannabinol (THC) (THC-dominant), (2) 11% cannabidiol (CBD) (CBD-dominant), (3) 6% THC + 11% CBD, and (4) placebo cannabis flower in a randomized order. Washout period between treated migraine attacks was ≥1 week. The primary endpoint was pain relief, and secondary endpoints were pain freedom and most bothersome symptom freedom, all assessed at 2-h post-vaporization.

Results: Ninety-two participants were enrolled and randomized, and 247 migraine attacks were treated. THC + CBD was superior to placebo at achieving pain relief (67.2% vs. 46.6%, odds ratio [95% confidence interval] 2.85 [1.22, 6.65], p = 0.016), pain freedom (34.5% vs. 15.5%, 3.30 [1.24, 8.80], p = 0.017), and most bothersome symptom freedom (60.3% vs. 34.5%, 3.32 [1.45, 7.64], p = 0.005) at 2 h, as well as sustained pain freedom at 24 h and sustained most bothersome symptom freedom at 24 and 48 h. THC-dominant was superior to placebo for pain relief (68.9% vs. 46.6%, 3.14 [1.35, 7.30], p = 0.008) but not pain freedom or most bothersome symptom freedom at 2 h. CBD-dominant was not superior to placebo for pain relief, pain freedom, or most bothersome symptom freedom at 2 h. There were no serious adverse events.

Conclusion: Acute migraine treatment with 6% THC + 11% CBD was superior to placebo at 2-h post-treatment with sustained benefits at 24 and 48 h.