View clinical trials related to Migraine.
Filter by:This study aims to investigate structural and functional cerebral changes using magnetic resonance imaging before and after treatment with erenumab in patients with migraine.
The purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.
This study aims to investigate the effect of erenumab on efficacy outcomes, tolerability outcomes, and patient-reported outcomes in individuals with migraine. Furthermore, the study aims to identify clinical predictors of erenumab response.
To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.
The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.
The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study). Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab. The total duration of the study is planned to be up to 84 months.
Migraine is the 2nd most disabling neurological disease. It affects 14.7% of the population (children and adults) of whom 80% are female. In the European Union, the total annual cost of migraine is of 111 billion euros. If not adequately treated, migraine can evolve into the more severe chronic form (CM), defined by >15 headache days/month, where burden and costs increase exponentially. Until very recently, available preventive treatments for migraine were non-specific, of limited efficacy and scarce tolerability. In 2018, monoclonal antibodies (mABs) against calcitonin gene-related peptide (CGRP) receptor have been approved. Since CGRP is one of the main modulators of the trigeminal system, mABs against CGRP are the first specific preventive treatment for migraine ever developed. They are highly effective in a subgroup of patients, well tolerated, but costly. In this frame, the main objective of BIOMIGA project is to identify predictive biomarkers of response to CGRP-mABs in patients with severe forms of migraine. To this end, the investigators will use an integrated hypothesis-based and data-driven, multidisciplinary approach that combines' omic testing in a deep-phenotyped migraine population and parallel fundamental research in a validated animal model of migraine. Three partners, Headache Science Centre, IRCCS C. Mondino Foundation, University of Pavia, Italy, Headache Research Group Vall d'Hebron Institute of Research, Barcelona, Spain and Institut für Systemische Neurowissenschaften, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany with an established long-standing and complementary expertise in neuroimaging, biochemical profiling and epigenetics in humans and in animal modeling of migraine will collaborate to achieve the Project's objective. The investigators expect important spin-offs to the improved management of migraine, both in terms of increased efficacy and cost saving, but also to understand CGRP-based mechanisms underlying migraine pathophysiology and to set the basis for a pathophysiologically driven classification. Healthcare providers and the pharmaceutical industry will be engaged once the biomarker(s) have been identified to optimize access to care and the use of resource, as well as to reduce disability and socio-economic impact of migraine.
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab The total duration of the study is planned to be 75 months.
A randomized, double-blind, placebo-controlled, parallel study to investigate the effect of erenumab in calcitonin-gene related peptide and cilostazol experimental models of migraine in humans. Followed by a 6-month open-label extension.
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.