Headache
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Randomized Controlled Trial Multicenter Study
Evaluation of the Pharmacokinetic Interaction of Ubrogepant Coadministered With Sumatriptan and of the Safety of Ubrogepant With Triptans.
To evaluate the potential for pharmacokinetic interaction and the safety and tolerability when ubrogepant and sumatriptan are coadministered in a Phase 1 study in healthy participants, and to inform the safety and tolerability of ubrogepant alone and in combination with triptans in Phase 3 trials in participants with migraine. ⋯ Although there were slight alterations in ubrogepant pharmacokinetic parameters when coadministered with sumatriptan, such changes are expected to have minimal clinical relevance, especially because no changes were seen in sumatriptan area under the curve and maximum plasma concentration when coadministered with ubrogepant. Coadministration of ubrogepant with sumatriptan was well tolerated in healthy participants in the Phase 1 study, and coadministration of ubrogepant with triptans was well tolerated in participants with migraine in the Phase 3 trials. No new safety concerns for ubrogepant were identified across all trials.
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The objective of this study was to examine if patients with migraine who responded sufficiently to acute treatment were significantly different from those who did not in terms of patient characteristics, treatment patterns, and patient level of impairment, and to identify characteristics associated with insufficient response. ⋯ Clinical characteristics, treatment patterns, and health-related quality of life measures are statistically significantly different between insufficient responders and responders to acute treatment in patients with migraine.
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To systematically identify risk factors for the development of post-traumatic headache (PTH) attributed to traumatic brain injury (TBI) as defined in the International Classification of Headache Disorders (ICHD). ⋯ We found that there is little evidence for any risk factors involved in the development of acute PTH, whereas no study had assessed risk factors for the development of persistent PTH. Further studies are warranted and should be powered to examine possible risk factors for the development of PTH. Rigorous methodology and standardized monitoring should be prioritized to support high-quality research and validate potential findings.
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Case Reports
Erenumab Efficacy on Comorbid Cluster Headache in Patients With Migraine: A Real-World Case Series.
Monoclonal antibodies (mABs) against calcitonin gene-related peptide (CGRP) or its receptor have emerged as effective and well-tolerated preventive medications for migraine. The key role played by CGRP has been recently demonstrated also in the pathophysiology of cluster headache (CH), paving the way for studies aimed to investigate the effectiveness of mABs targeting CGRP also in CH. However, no trials have been conducted so far to test the efficacy and tolerability of erenumab as CH preventive treatment. ⋯ Our findings support the efficacy and tolerability of monthly erenumab 140 mg as a preventive treatment in patients suffering from both migraines without aura and CH. We speculate that erenumab could represent a low-risk alternative for CH patients (with or without comorbid migraine) who did not tolerate common CH preventatives therapies or for whom the therapies were not successful. Certainly, randomized trials are needed to confirm these observations and we hope that our data, showing a delayed therapeutic effect only with the highest dose of erenumab (140 mg/month), can be taken into account in designing future trials.
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Headache attributed to mild traumatic injury of the head (aka: mild traumatic brain injury, mTBI), frequently abbreviated to Post-Traumatic Headache (PTH), is one of the most common and disabling symptoms after a head injury. PTH often phenotypes to migraine. Evidence for treating PTH in the pediatric population is limited. Widely accepted guidelines do not exist to aid the clinician and there are currently no placebo-controlled trials for the pharmacologic management of PTH in this age group. Recommendations for when to return a child or adolescent to sport if they develop and/or are being treated for persistent PTH (PPTH) are lacking. The objective of this narrative review is to review the implications of returning an adolescent with PPTH to sport. ⋯ The authors recommend that strict adherence to the guidelines that return to sport cannot occur until a child is symptom free at rest, off any medication, may be unreasonable in certain situations. Symptom stability is the proposed new concept for return to sport.