Estudio primario

No clasificado

Año 2017
Autores [No se listan los autores]
Revista Journal of Headache and Pain
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The proceedings contain 313 papers. The topics discussed include: the clinical efficacy of short-lasting ketogenic diet in migraine is due to a general normalization of the interictal cortical hyperresponsivity rather than to a direct modulation of the subcortical brainstem activity; efficacy of erenumab in subjects with episodic migraine with prior preventive treatment failure(s); phase 3, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab (AMG 334) in migraine prevention: primary results of the STRIVE trial; GLP-1 reduces cerebrospinal fluid secretion and intracranial pressure: a novel treatment for idiopathic intracranial hypertension?; interventional management in refractory headache disorders; tertiary center based experiences supported by application videos and a model for interactive practice of attenders; a phase 3 placebo-controlled study of galcanezumab in patients with chronic migraine: results from the 3-month double-blind treatment phase of the REGAIN study; rare primary headaches in Italian tertiary headache centres: a nationwide retrospective epidemiologic survey (RegistRare study); improving the differential diagnosis between migraine with aura and transient ischemic attacks; non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: the randomised controlled PRESTO trial; differences between episodic and chronic migraine in white-matter tracts: a diffusion-tensor imaging study; cerebral grey matter density is abnormally reduced in chronic migraine patients: correlations with clinical features; and the relationship between pain, psychiatric, and endocrine/neurological comorbidities of migraine: results from the chronic migraine epidemiology and outcomes (CaMEO) study.

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Año 2024
Revista Cephalalgia
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Background: The cAMP and cGMP pathways are implicated in the initiation of migraine attacks, but their interactions remain unclear. Calcitonin gene-related peptide (CGRP) triggers migraine attacks via cAMP, whereas the phosphodiesterase-5 inhibitor sildenafil induces migraine attacks via cGMP. Our objective was to investigate whether sildenafil could induce migraine attacks in individuals with migraine pre-treated with the CGRP-receptor antibody erenumab. Methods: In this randomized, double-blind, placebo-controlled, cross-over study, adults with migraine without aura received a single subcutaneous injection of 140 mg erenumab on day 1. They were then randomized to receive sildenafil 100 mg or placebo on two experimental days, each separated by at least one week, between days 8 and 21. The primary endpoint was the difference in the incidence of migraine attacks between sildenafil and placebo during the 12-h observation period after administration. Results: In total, 16 participants completed the study. Ten participants (63%) experienced a migraine attack within 12 h after sildenafil administration compared to three (19%) after placebo (p = 0.016). The median headache intensity was higher after sildenafil than after placebo (area under the curve (AUC) for the 12-h observation period, p = 0.026). Furthermore, sildenafil induced a significant decrease in mean arterial blood pressure (AUC, p = 0.026) and a simultaneous increase in heart rate (AUC, p < 0.001) during the first hour after administration compared to placebo. Conclusion: These findings provide evidence that migraine induction via the cGMP pathway can occur even under CGRP receptor blockade. Trial registration: ClinicalTrials.gov: Identifier NCT05889455.

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Estudio primario

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Año 2023
Registro de estudios ClinicalTrials.gov
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This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN).

This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies:

* Investigational Drug Sub-Study A: Siltuximab
* Investigation Drug Sub-Study B: Erenumab-Aooe

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