Cephalalgia : an international journal of headache
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Background Functional connectivity of brain networks may be altered in migraine without aura patients. Functional magnetic resonance imaging (fMRI) studies have demonstrated changed activity in the thalamus, pons and cerebellum in migraineurs. Here, we investigated the thalamic, pontine and cerebellar network connectivity during spontaneous migraine attacks. ⋯ There was decreased functional connectivity between the right thalamus and three ipsilateral brain areas (primary somatosensory cortex and premotor cortex). We found no change in functional connectivity in the pontine or the cerebellar networks. Conclusions The study indicates that network connectivity between thalamus and pain modulating as well as pain encoding cortical areas are affected during spontaneous migraine attacks.
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Objectives To explore the validity of the roller pressure algometer as a new tool for evaluating dynamic pressure sensitivity by assessing its association with pain features and widespread pressure pain sensitivity in migraine women, and also to determine whether dynamic pressure algometry differentiates between episodic and chronic migraine. Methods One hundred and twenty women with migraine (42% chronic, 58% episodic) participated. Dynamic pressure sensitivity was assessed with a set of roller pressure algometers (Aalborg University, Denmark®) consisting of 11 rollers with fixed pressure levels from 500 to 5300 g. ⋯ Conclusions Roller pressure algometry was valid for assessing dynamic pressure sensitivity in migraine in the trigeminal area and is consistent with widespread static pressure pain sensitivity. Roller, but not static, pressure algometry differentiated between episodic and chronic migraine. Assessing static and dynamic deep somatic tissue sensitivity may provide new opportunities for evaluating treatment outcomes.
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Randomized Controlled Trial Multicenter Study
Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study.
Background Safety findings from a Phase 2b study of galcanezumab, a humanized monoclonal antibody against calcitonin gene-related peptide, for prevention of migraine (NCT02163993) are reported here. Methods Patients aged 18-65 years with episodic migraine were evaluated in this multicenter, double-blind, randomized study. After randomization, 410 patients were administered 5, 50, 120 or 300 mg of galcanezumab or placebo subcutaneously once every 4 weeks for 12 weeks, followed by a post-treatment off-drug period lasting 12 weeks. ⋯ Potential hypersensitivity events were reported at similar frequencies in galcanezumab (3.3%) and placebo (5.1%) groups. Incidence of treatment-emergent anti-drug antibodies in galcanezumab dose groups (4.6% of patients during treatment period) did not appear to have any meaningful effects on safety, the pharmacokinetics of galcanezumab, or its ability to bind to the target ligand. Conclusion The results from this 3-month Phase 2b study support the initiation of larger Phase 3 trials of longer duration.
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Multicenter Study Observational Study
A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study).
Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. ⋯ There were no serious adverse events. Conclusions This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number NCT02357381.
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Randomized Controlled Trial
ARISE: A Phase 3 randomized trial of erenumab for episodic migraine.
Background Calcitonin gene-related peptide plays an important role in migraine pathophysiology. Erenumab, a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, is being evaluated for migraine prevention. Methods In this randomized, double-blind, placebo-controlled, phase 3 study, 577 adults with episodic migraine were randomized to placebo or 70 mg erenumab; 570 patients were included in efficacy analyses. ⋯ Most frequent adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Conclusions As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use. (Funded by Amgen). Trial registration ClinicalTrials.gov, NCT02483585.