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Introduction
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Publications
Publications (112)
Objectives
To determine whether extending anti-CGRP mAb treatment beyond 3 years influences migraine course, we analyzed migraine frequency during the first month of treatment discontinuation following three 12-month treatment cycles (Ts).
Methods
This multicenter, prospective, real-world study enrolled 212 patients with high-frequency episodic mi...
Background: The advent of monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway has transformed the management of migraine, offering newfound optimism for clinicians and individuals with episodic migraine (EM) and chronic migraine (CM). While randomized controlled trials (RCTs) have provided crucial insights into...
Background The advent of monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway has transformed the management of migraine, offering newfound optimism for clinicians and individuals with episodic migraine (EM) and chronic migraine (CM). While randomized controlled trials (RCTs) have provided crucial insights into the...
We conducted a multicenter, prospective study (EMBRACE) evaluating the real-life effectiveness, safety, and tolerability of eptinezumab (100 mg/300 mg)—a monoclonal antibody targeting the calcitonin-gene-related peptide (anti-CGRP mAb)—in high-frequency episodic migraine (HFEM) or chronic migraine (CM). The primary endpoint was the change in monthl...
Background
Anti-CGRP monoclonal antibodies (anti-CGRP MAbs) are approved and available treatments for migraine prevention. Patients do not respond alike and many countries have reimbursement policies, which hinder treatments to those who might respond. This study aimed to investigate clinical factors associated with good and excellent response to a...
Long-term (1-year) fremanezumab treatment proved to be effective, safe, and well tolerated in individuals with migraine and < 2 medication clusters in a randomized controlled trial (RCT). We aimed to assess real-world evidence (RWE), long-term effectiveness, tolerability, and safety of fremanezumab in people with high-frequency episodic migraine (H...
Objectives
While a single 12-month treatment cycle (TrC) with anti-CGRP mAbs is not disease-modifying for most patients, there is limited understanding of the effects of multiple TrCs on migraine course. We evaluated whether a second TrC might modify the migraine course by comparing the occurrence of migraine relapse after discontinuation of the se...
Objective
Nearly 60% of migraine patients treated with monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway experience a ≥ 50% reduction in monthly migraine days (MMD) at 12 weeks compared to baseline (responders). However, approximately half of the patients not responding to anti-CGRP mAbs ≤ 12 weeks do respond...
Background
Migraine is the second world’s cause of disability. Among non-pharmacological treatments, nutritional intervention, particularly ketogenic diet, represents one of the most promising approaches.
Methods
This a prospective, single center, randomized, controlled study aimed at evaluating the efficacy of a very low-calorie ketogenic diet (V...
Objectives
To assess frequency and characteristics of late responders (>12 weeks) to monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP).
Methods
This is a multicenter (n=16), prospective, real-life study, considering all consecutive adults with high frequency or chronic migraine treated with anti-CGRP mAbs for > 24 w...
Abstract Background To verify the long-term (24-week) efficacy, safety, and tolerability of fremanezumab in real-life patients with high-frequency episodic migraine (HFEM: ≥ 8 days/month) or chronic migraine (CM: ≥ 15 days/month), and multiple preventive treatment failures. Methods This is a prospective, cohort, real-life study at 28 headache cente...
Background
To verify the long-term (24-week) efficacy, safety, and tolerability of fremanezumab in real-life patients with high-frequency episodic migraine (HFEM: ≥8 days/month) or chronic migraine (CM: ≥15 days/month), and multiple preventive treatment failures.
Methods
This is a prospective, cohort, real-life study at 28 headache centers on cons...
Background
Monoclonal antibodies acting on the calcitonin gene-related peptide (CGRP) or its receptor have changed migraine preventive treatment. Those treatments have led to reconsidering the outcomes of migraine prevention. Available data mostly considered benefits in terms of relative efficacy (percent or absolute decrease in monthly migraine da...
Background:
Fremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explor...
Background and objectives
The identification of predictors of response to antiCGRP mAbs could favor tailored therapies and personalized treatment plans. This study is aimed at investigating predictors of ≥ 50%, ≥ 75% and 100% response at 24 weeks in patients with high-frequency episodic (HFEM: 8–14 days/month) or chronic migraine (CM).
Methods
Thi...
Background:
To evaluate the one-year effectiveness and tolerability of galcanezumab in real life and the prognostic indicators of persistent response.
Methods:
High-frequency episodic migraine (HFEM) and chronic migraine (CM) patients treated with galcanezumab who completed a one-year observation were enrolled. The primary outcomes assessed duri...
Objective
To investigate in real-life the conversion from chronic migraine (CM) to episodic migraine (EM), specifically to EM with High-Frequency (HFEM: 8–14 monthly migraine days, MMDs), Medium-Frequency (MFEM, 4–7 MMDs), and Low-Frequency EM (LFEM, 0–3 MMDs), and its persistence during 1 year of treatment with galcanezumab.
Methods
Consecutive C...
Background
Fremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explores...
Background
The clinical benefit of galcanezumab, demonstrated in randomized clinical trials (RCTs), remains to be quantified in real life. This study aimed at evaluating the effectiveness, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic migraine (CM) in a real-life setting.
Methods
T...
Background
Monoclonal antibodies anti-calcitonin gene-related peptide (mAbs anti-CGRP) pathway are effective and safe on migraine prevention. However, some drug agencies limited these treatments to one year due to their high costs. This study aimed at evaluating the effect of discontinuing mAbs anti-CGRP on monthly migraine days (MMDs) and disabili...
Background: The monoclonal antibodies anti-calcitonin gene-related peptide (mAbs anti-CGRP) pathway revolutionized migraine prevention. However, some drug agencies limited the treatment to one year due to their high costs. This study aimed at evaluating the effect of discontinuing mAbs anti-CGRP on monthly migraine days (MMDs) and disability in hig...
Background
A rapid response to preventive therapy is of pivotal importance in severely disabled patients with chronic migraine (CM) and diverse preventive failures. This prospective, observational, multicenter real-life study aimed at investigating the effectiveness of galcanezumab in the first three months of treatment of CM patients at 14 Italian...
Objective:
To evaluate the long-term effectiveness, safety, and tolerability of erenumab in a real-world migraine population, looking for putative predictors of responsiveness.
Background:
Erenumab proved to be effective, safe, and well tolerated in the prevention of episodic migraine (EM) and chronic migraine (CM) in long-term extension studies...
Headaches are among the most prevalent and disabling neurologic disorders and there are several unmet needs as current pharmacological options are inadequate in treating patients with chronic headache, and a growing interest focuses on nutritional approaches as non-pharmacological treatments. Among these, the largest body of evidence supports the u...
Headaches are among the most prevalent and disabling disorders and there are several patients’ unmet needs in current pharmacological options, while a growing interest is focusing on nutritional approaches as non-pharmacological treatments. Among these, the most promising seems to be the ketogenic diet (KD). Exactly 100 years ago, KD was used to tr...
Objective:
To assess the effectiveness, safety, and tolerability of erenumab in a real-life migraine population, while trying to identify responsiveness predictors.
Background:
Erenumab is a fully human Ig-2 monoclonal antibody blocking the calcitonin gene-related peptide receptor, indicated for migraine prophylaxis. Phase II and III trials demo...
Objectives:
The COVID-19 pandemic and the consequent lockdown came as a storm disrupting people's everyday life. This study aimed at observing whether the COVID-19 related lockdown influenced migraine frequency and disability in migraine patients on therapy with monoclonal antibodies inhibiting the CGRP pathway.
Methods:
In this longitudinal obs...
Purpose:
Migraine is an exclusively human chronic disorder with ictal manifestations characterized by a multifaceted clinical complexity pointing to a cerebral cortical involvement. The present review is aimed to cover the clinical, neuroimaging, and neurophysiological literature on the role of the cerebral cortex in migraine pathophysiology.
Ove...
Botulinum neurotoxin is widely used for the treatment of central and peripherical neurological conditions. Initially used to treat strabismus, over the years its use has been expanded also to spasticity and other neurological disorders. This review summarizes the evidence from the published literature regarding its effect on neuropathic pain. Almos...
Background: Migraine is very common in women of childbearing age. Erenumab is a first-in-class anti-CGRP monoclonal antibody with a a favorable efficacy/tolerability profile. However, there are very limited data on its effects during pregnancy.
Case presentation: We report a case of a 37-years-old woman affected by chronic migraine who became pregn...
Background
Dopaminergic symptoms may be extremely pronounced in some migraine patients during the attack, representing a major source of disability.
Objectives
We aimed to carefully characterize the clinical picture of migraine patients with dopaminergic symptoms in a large patients’ population as a putative migraine endophenotype, allowing more p...
Machine learning (ML) is largely used to develop automatic predictors in migraine classification but automatic predictors for medication overuse (MO) in migraine are still in their infancy. Thus, to understand the benefits of ML in MO prediction, we explored an automated predictor to estimate MO risk in migraine. To achieve this objective, a study...
Trigeminal‐targeted treatments (TTTs), the most specific and selective therapeutic migraine approach to date, are effective in approximately 60% of patients regardless of treatment type or mechanism, at least if used alone. Sixty percent is also the proportion of migraineurs who develop migraine‐like episodes following experimental intravenous admi...
Dopamine-beta-hydroxylase (DBH) enzyme activity is modulated at the genetic level by the presence of several polymorphisms. Among these, the 19-bp insertion/deletion (I/D) polymorphism (rs72393728/rs141116007) was investigated in several genetic association studies for its correlation with the susceptibility to develop episodic migraine, but confli...
Migraine is a pure human neurovascular disorder with no reliable corresponding animal model. The cerebral cortex (CC) has long been discussed as a crucial element of its complex mechanism. The present review considers the state of the art of experimental evidence on the involvement of CC in migraine. An ample series of research data points to a rol...
Background:
Migraine is the most common neurological disorder and the second most disabling human condition, whose pathogenesis is favored by a combination of genetic, epigenetic, and environmental factors. In recent years, several efforts have been made to identify reliable biomarker(s) useful to monitor disease activity and/or ascertain the resp...
To optimize chronic migraine (CM) ascertainment and phenotype definition, provide adequate clinical management and health care procedures, and rationalize economic resources allocation, we performed an exploratory multicenter pilot study aimed at establishing a CM database, the first step for developing a future Italian CM registry. We enrolled 63...
•1/3 or migraineurs refers DAergic symptoms (usually >3) during the attack; •DAergic symptoms are usually presynaptic (yawing and somnolence) and occur mainly during the headache stage. •Migraine attacks are longer and more frequently associated with osmophobia, allodynia and vomiting in DA+ than in general migraine population. •DA+ seem to be char...
Objectives. Dopamine (DA) is considered to play a major role in migraine pathogenesis as suggested by clinical, genetic, biochemical and pharmacological evidence. The present study was designed to assess frequency and characteristics of DAergic pre-synaptic (yawning, somnolence, neck discomfort/stiffness) and post-synaptic (intense nausea, vomiting...
Ketogenic diet (KD) is an established treatment for refractory pediatric epilepsy and a promising therapy for diverse neurological diseases. Clinical data on KD in migraine—obtained from 150 patients investigated in case reports and prospective studies—suggest that KD may be a rapid onset effective prophylaxis for episodic and chronic migraine. KD...
Recent clinical experiences and clinical trials have demonstrated the safety, tolerability, and efficacy of non-invasive vagus nerve stimulation (nVNS; gammaCore®) for the acute and prophylactic treatment of migraine. nVNS has a favorable adverse event profile, making it an attractive option for sensitive patient populations. We explored the safety...
Calcitonin gene-related peptide (CGRP), a potent vasodilator and pain-signaling neuropeptide, is a validated therapeutic target for migraine and cluster headache. Four anti-CGRP monoclonal antibodies (mAbs) have been developed, representing the first specific, mechanism-based, migraine prophylactic treatment. CGRP mAbs demonstrated good efficacy co...
Introduction: Research has focused on serotonin (5-HT) 5-HT1D and 5-HT1F receptors to develop drugs acting through non-vasoconstrictive mechanisms for treating acute migraine and those targeting 5-HT2B and 5-HT7 receptors for preventing migraine.
Areas covered: This paper reviews antimigraine drugs targeting 5-HT receptors in one phase I trial (sum...
Background
Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrua...
Background:
Migraine with unilateral cranial autonomic symptoms (UAS) is a putative migraine endophenotype with convincing response to trigeminal-targeted treatments that still needs a thorough characterization.
Objective:
The objective of this article is to carefully investigate the clinical phenotype of migraine with UAS in a large group of pa...
The study of COMT gene polymorphisms in migraine could be of particular interest since impaired catecholaminergic neurotransmission, namely chronic dopaminergic and noradrenergic hypofunction, is a peculiar migraine trait. In this study, for the first time, we focused on the role of COMT rs4818 genetic variant, the polymorphism most strongly affect...
The treatment of migraine headache is challenging given the lack of a standardized approach to care, unsatisfactory response rates, and medication overuse. Neuromodulation therapy has gained interest as an alternative to pharmacologic therapy for primary headache disorders. This study investigated the effects of non-invasive vagus nerve stimulation...
As many as 14-21 million people worldwide (0.3-0.5% of the population, aged 15-65 years) use cocaine [1]. In Europe, cocaine consumption has shown a 2- to 3-fold increase during the last 2 decades [2,3]; in Italy, lifetime cocaine experience among adults corresponds to 6.6% [4]. Cocaine use and headache share some common characteristics: present he...
Chronic migraine is a severely disabling headache evolving from episodic migraine as a result of different transforming factors and characterized by atypical pain modulation and peripheral and central sensitization. Discovered by serendipity, onabotulinum toxin A (BoNT-A) represents the only drug specifically approved for CM prophylaxis. According...
Most pharmacological trials deal with migraine as if it were a clinically homogeneous disease, and when detailing its characteristics, they usually report only the presence, or absence, of aura and attack frequency but provide no information on pain location, a non-trivial clinical detail. The past decade has witnessed growing emerging evidence sug...
Progesterone influences central neuronal excitability, a key event in migraine pathophysiology. Progesterone receptor gene (PGR) rs1042838 (G/T - Val660Leu) variant is indicative of PROGINS haplotype and associated to a reduced PGR activity. With the aim of investigating whether any type of association existed between this genetic variant and migra...
Several studies suggest a role of oxidative stress in the physiopathology of migraine, particularly in the form with aura. In a case-control study, we investigated the association between migraine and SOD1 and SOD2 genes in a cohort of 490 consecutive unrelated Caucasian migraineurs (migraine with aura - MwA n=107, migraine without aura - MwoA n=24...
Several studies suggest that an increased oxidative stress is a key event in migraine, especially in the form with aura. One of the most efficient first line antioxidant defense system of cells exposed to oxygen is Superoxide Dismutase (SOD) system. The SOD1 gene presents a polymorphism (A/C substitution - rs2234694) resulting in lower serum activi...
Introduction:
Ample evidence that nitric oxide (NO) is a causative molecule in migraine has encouraged research to develop drugs that target the NO-cGMP cascade for migraine treatment. NO synthase (NOS) inhibition is an innovative therapeutic principle.
Areas covered:
This paper reviews the rationale underlying NOS inhibition in migraine treatme...
Tension-type headache (TTH) is the second most common human disease, accounting for intense disability, high costs and numerous workdays lost. Tension-type headache is less simple and easy-to-treat than commonly thought. Antidepressants, despite their poor tolerability, are still the first-choice drugs for preventing TTH. The most widely studied no...
Headache is one of the most common symptoms after cocaine use.
We investigated headache frequency and characteristics and the correlation between headache and acute cocaine intake in a cross-sectional study in a consecutive series of chronic cocaine users.
Participation rate was 94.1%. Of the 80 subjects enrolled, 72 (90%) reported current headache...
Aim:
In the present case-control study, we investigated the correlation between the common ACE insertion/deletion (I/D) polymorphism and migraine.
Materials & methods:
Genotyping of the ACE I/D variant was performed in 502 Caucasian patients with migraine and 323 age-, sex- and race/ethnicity-matched healthy controls. We investigated association...
To describe the clinical findings in a family with a benign form of mesial temporal lobe epilepsy and to identify the causative genetic factors.
All participants were personally interviewed and underwent neurologic examination. The affected subjects underwent EEG and most of them neuroradiological examinations (MRI). All family members were genotyp...
Idiopathic photosensitive occipital lobe epilepsy (IPOE) is an idiopathic localization-related epilepsy characterized by age-related onset, specific mode of precipitation, occipital photic-induced seizures - frequently consisting of visual symptoms - and good prognosis. This uncommon epilepsy, which usually starts in childhood or adolescence, has r...
Juvenile myoclonic epilepsy (JME) is a frequent idiopathic generalised epilepsy syndrome with typical clinical and EEG features that can usually be controlled by valproate monotherapy. JME may be underdiagnosed or misdiagnosed; in the latter case, it may be mistaken for partial epilepsy. The incorrect diagnosis of JME is likely to result in inappro...
Migraine pain is often preceded, accompanied and followed by dopaminergic symptoms (premonitory yawning and somnolence, accompanying nausea and vomiting, postdromal somnolence, euphoria and polyuria). After reviewing evidence from pharmacological, biochemical, genetic and animal experimental studies on the relationship between dopamine and migraine...
Purpose:
In relatively small series, autosomal dominant lateral temporal epilepsy (ADLTE) has been associated with leucine-rich, glioma-inactivated 1 (LGI1) mutations in about 50% of the families, this genetic heterogeneity being probably caused by differences in the clinical characteristics of the families. In this article we report the overall c...
Prion protein, a sialoglycoprotein with neuroprotective properties on oxidative stress damage, has been related with the mechanisms leading to migraine. In the present case-control study, we investigated the correlation between the common methionine/valine polymorphism at codon 129 within the prion protein gene (PRNP) and migraine. Genotyping of PR...
The development of Biobanks and recent advances in molecular biology have enhanced the possibility to accelerate translational research studies. The Interinstitutional Multidisciplinary BioBank (BioBIM) is organized in a large healthy donors collection and pathology-based biobanks with the aim to provide a service for development of interdisciplina...
Background:
Excessive daytime sleepiness is a major clinical and health concern that can have varied and sometimes harmful consequences. Findings from uncontrolled studies suggest a high prevalence in patients with chronic migraine.
Methods:
In a case-control study, we compared frequency data for excessive daytime sleepiness in 100 patients with...
Objective.— To clarify the frequency and characteristics of altered transverse sinus morphology in a series of consecutive patients with chronic migraine.
Background.— As terminology, neuroradiological techniques and patient selection differ widely across various studies, reliable, reproducible information is lacking on the frequency of cerebral tr...
Migraine prevention hinges on a variety of non-specific drugs that mainly reduce neuronal hyperexcitability, the putative pathophysiological hallmark for migraine. The improved knowledge about migraine circuitry and neurobiology has prompted research to develop new specific migraine preventive medications targeted to innovative sites and mechanisms...
The objective and background is to confirm in a double-blind, placebo-controlled study the high triptan response rates we had previously reported in an open study in migraine patients with unilateral cranial autonomic symptoms. In this randomized, double-blind, placebo-controlled study 80 migraineurs with unilateral cranial autonomic symptoms were...
Epilepsy and migraine are common neurologic chronic disorders with episodic manifestations characterized by recurrent attacks and a return to baseline conditions between attacks. Epilepsy and migraine are frequently observed in comorbidity, with the occurrence of one disorder increasing the probability of the other: Migraine occurs in about one-fou...
We report on a 64 year-old woman presenting with Epilepsia Partialis Continua (EPC) affecting the left hand since the age of 24 without neurological deficit. Structural MRI showed a region of focal cortical dysplasia (FCD) over the right central gyrus and lesions in the mesial frontal and occipital cortex secondary to perinatal hypoxic injury. Icta...
A wide array of options are now available for migraine prophylaxis. Conventional treatments include beta-blockers, anticonvulsants, antidepressants, calcium antagonists and antiserotoninergic drugs. Emerging medications such as ACE inhibitors, sartans and nutritional supplements are gaining favour for migraine prophylaxis. Botulinum toxin type A is...
To describe the clinical and genetic findings of four families with autosomal dominant lateral temporal epilepsy.
A personal and family history was obtained from each affected and unaffected subject along with a physical and neurologic examination. Routine electroencephalography and magnetic resonance imaging (MRI) studies were performed in almost...
The KCNAB1 gene is a candidate susceptibility factor for lateral temporal epilepsy (LTE) because of its functional interaction with LGI1, the gene responsible for the autosomal dominant form of LTE. We investigated association between polymorphic variants across the KCNAB1 gene and LTE. The allele and genotype frequencies of 14 KCNAB1 intronic SNPs...
Autosomal dominant lateral temporal epilepsy (ADTLE) is an inherited epileptic syndrome characterized by ictal auditory symptoms or aphasia, negative MRI findings, and relatively benign evolution. Mutations responsible for ADLTE have been found in the LGI1 gene. The functions of the Lgi1 protein apparently are mediated by interactions with members...