Lancet neurology
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Randomized Controlled Trial
Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial.
Patients and clinicians share concerns that generic drug substitution might lead to loss of efficacy or emergence of adverse events. In this trial, we assessed US Food and Drug Administration (FDA) bioequivalence standards by studying the effects of switching between two disparate generic immediate-release lamotrigine products in patients with epilepsy. ⋯ American Epilepsy Society, Epilepsy Foundation, and US Food and Drug Administration.
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Brain imaging has a crucial role in the presurgical assessment of patients with epilepsy. Structural imaging reveals most cerebral lesions underlying focal epilepsy. Advances in MRI acquisitions including diffusion-weighted imaging, post-acquisition image processing techniques, and quantification of imaging data are increasing the accuracy of lesion detection. ⋯ PET, SPECT, simultaneous EEG and functional MRI, and electrical and magnetic source imaging can be used to infer the localisation of epileptic foci and assist in the design of intracranial EEG recording strategies. Progress in semi-automated methods to register imaging data into a common space is enabling the creation of multimodal three-dimensional patient-specific datasets. These techniques show promise for the demonstration of the complex relations between normal and abnormal structural and functional data and could be used to direct precise intracranial navigation and surgery for individual patients.
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Randomized Controlled Trial
Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial.
The calcitonin gene-related peptide (CGRP) pathway is a promising target for preventive therapies in patients with migraine. We assessed the safety and efficacy of AMG 334, a fully human monoclonal antibody against the CGRP receptor, for migraine prevention. ⋯ Amgen.