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101 active trials for Migraine

Amitriptyline vs GON and SON Blocks in Migraine

Comparison of efficacy and safety of amitriptyline and nerve blocks

Start: April 2021

CandeSpartan Study. Candesartan Spanish Response-prediction and Tolerability Study

Observational, prospective, descriptive, open study on response predictors and tolerability of Candesartan in patients >18 years with episodic or chronic migraine with prior failure of three or more preventive drugs. Patients will receive Candesartan the same manner and intensity if they were not enrolled in the study. Vital signs, clinical variables and adverse events will be monitored. Primary endpoint will be to determine demographic and clinical factors associated with a 50% reduction in the frequency of headache days per month between weeks 20 and 24 compared with baseline.

Start: January 2020

Mind and Body Approaches to Pain Reduction in Youth With Migraine

The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study design of this mechanistic investigation includes functional magnetic resonance imaging (fMRI), daily headache diaries, assessment of conditioned pain modulation via quantitative sensory testing, and validated psychometric assessments before and after the delivery of one of five treatments over an 8 week period [cognitive behavioral therapy (CBT), biofeedback-assisted relaxation training (BART) and cognitive reappraisal (CR) training, amitriptyline, and placebo]. We are examining both distinct and common pathways that may help explain the response to various preventive treatments, as well as potential predictors of outcome.

Start: October 2018

An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches

This study aims to conduct an initial evaluation of whether a single, online, group-based session of hypnosis followed by self-hypnosis can decrease symptoms of migraine and tension-type headaches as well as improve quality of life and perceived self-efficacy over the condition.

Start: October 2020

Auditory Functions in Patients With Migraine

Migraine is a neurological disease associated with an altered cortical excitability level . The prevalence of migraine is10.5% of adults in Assiut governorate, and is more frequent in women and in individuals with higher education level . There is evidence that migraine patients could present cognitive deficits, being the affected functions memory, processing information speed and attention. It was found that the prevalence of migraine in AlQuseir was 4.8/100 and the highest figures found during early adult life(18-40) years old .Patients with migraine found to perform significantly worse in duration pattern test(DPT),non-verbal dichotic test ,speech in noise (SPIN)test and found to have longer p300 frequency stimulus latency which indicate presence of cognitive and central auditory processing dysfunction

Start: October 2021

Peripheral Electrical Stimulation for Migraine Prevention

Migraine is a common and disabling disease that affects more than 10% of the population worldwide. The prevalence of migraine in Taiwan is around 9.1%. The migraineurs missed 2 workdays due to migraine per year, that is 3.7 million estimated missed workdays in total and an estimated cost of 4.6 billion New Taiwan dollars. In addition, some migraineurs have poor response to the medications or suffer from adverse effects, and may further develop medication-overuse headache. Therefore, in recent years, efforts have been made to develop non-medication treatments, and the number of studies using neuromodulation as an intervention has increased dramatically. Among them, peripheral electrical stimulation has long been a routine treatment for pain in the clinic, and research has also shown its good evidence. In addition, recent studies have shown that peripheral electrical stimulation can also alter the cortical activities. Compared with the proximal brain stimulation, the remote electrical stimulation is safer, more convenient, less expensive and suitable for home use. To date, only one research had focused on the immediate anesthetic effect of remote electrical stimulation whereas the research for migraine prevention is still absent. Therefore, we expect to utilize a more remote electrical stimulation than trigeminal nerve electrical stimulation, which is the commonly used research method nowadays, as an interventional model. In three years, we will recruit 80 migraineurs along with 40 healthy controls and investigate the effects of 8-week home-based remote electrical stimulation on the prevention of migraine and the mechanisms using brain imaging, electrophysiological and biochemical examinations. We also aim to identify the predictors of the responders to remote electrical stimulation. If the effects of remote electrical stimulation are confirmed, as a non-drug neuromodulation management with features of non-invasive, low adverse effects and high accessibility, it will greatly lower the cost of social health care and better improve the quality of life and clinical status of the migraineurs.

Start: February 2021

Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden

This study is being conducted to evaluate the efficacy and safety of AJOVY (fremanezumab-vfrm) on interictal migraine related burden in adults.

Start: December 2020

Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study

To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control.

Start: February 2021

A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients That Are Not Helped by Previous Preventive Treatments

Evaluation of eptinezumab in the prevention of migraine in patients with unsuccessful prior preventive treatments

Start: June 2020

Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

This is a pilot feasibility acceptability study to examine the impact of smartphone-based progressive muscle relaxation (PMR) on migraine quality of life, frequency, intensity, and disability. Feasibility is measured by: a) Proportion of patients who enrolled in the study/were recruited for the study, b) Number of days PMR practiced/week as determined with the backend analytics in the RELAXaHEAD app, c) Minutes/day spent doing PMR, d) Reasons for non-adherence. Acceptability is measured by: a) Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality b) Willingness to repeat a similar treatment intervention in the future (Definitely No/Probably No/Unsure/Probably Yes/ Definitely Yes) c) Attrition. In addition, whether use of electronically based PMR introduced in the ED improves migraine quality of life (MSQv2) at 3 months post ED-discharge (or post enrollment date if recruited post ED discharge) compared to those who are not introduced to PMR will be assessed. All participants (N=85) will complete a migraine quality of life assessment and track their headache frequency and intensity using our smartphone application (app).

Start: June 2019

Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department

The purpose of the study is to determine the effect of intranasal lidocaine on pain score in pediatric patients with migraine. Patients with significant pain after oral analgesics and plan for intravenous (IV) abortive therapy will be asked to participate. Half of patients will be given intranasal lidocaine and the other half will be given placebo. Pain scores and associated migraine symptoms (i.e. nausea, vomiting, photophobia, phonophobia, avoidance of activities, and aura) will be monitored and compared between the groups.

Start: October 2018

Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment

This study aims to investigate structural and functional cerebral changes using magnetic resonance imaging before and after treatment with erenumab in patients with migraine.

Start: October 2020

Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Start: November 2018

Pain Biomarker Study

This study investigates molecular and physical biomarkers of headaches in order to better understand mechanisms of these diseases. There are 3 main parts: Use of capsaicin (active ingredient in hot chili peppers) to trigger release of calcitonin gene related peptide - the hypothesis is that this will be different in headache subjects compared to controls (and if so might be used to predict how these patients will respond to certain medications that modulate calcitonin gene-related peptide). Subjects will be given capsaicin as a cream applied to the forehead or the inner nostril, or a hot sauce that is ingested. Use of capsaicin to trigger eye watering - the hypothesis is that oxygen gas will slow down the amount of eye watering. Cluster headache patients respond very powerfully to oxygen gas but to very little else. The mechanism for oxygen is unknown but in rodents there is data that it works on the parasympathetic / lacrimal gland system. This study translates rodent data into humans in a non-invasive way to confirm the mechanism of this very effective treatment. Use of ice water to trigger headaches - brain freeze causes a very short-lived but intense headache that may cause similar biomarker release as other headache disorders. This may be a useful human model for other headache disorders.

Start: March 2018

Registry for Migraine - Clinical Core

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.

Start: September 2020

Efficacy of Erenumab on Functional Impact of Migraine

The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine in adults.

Start: October 2020

Vibratory Stimulation for the Treatment of Chronic Pain

The purpose of this study is to perform a first in man study with VCR stimulation of the belly and back for patients with chronic pain conditions including pelvic pain, functional abdominal pain, or low back pain. This study will also examine VCR stimulation of the temporal region for patients with migraine with or without aura. Additional goals of the study will be to determine the safety, tolerability, and acceptability of VCR stimulation for the treatment of these pain conditions.

Start: September 2021

RCT of IV Dexamethasone to Prevent Relapse in the Treatment of Migraine in a Paediatric ED

Background: Headaches is one of the most common complaints of children in the ED and the treatment of pediatric migraine is largely based on extrapolation data from adult studies, limited pediatric trials, clinical experience and expert consensus. Despite the fact that dexamethasone has already been proven effective to reduce recurrence and is currently used in treating adults with migraine, no studies have looked at its use in the treatment of childhood migraine where relapse rate of about 50% are described in the 48h following successful treatment in the ED. Objective: To examine the effectiveness of parenteral dexamethasone at preventing migraine recurrence in children and to study the risk factors for migraine relapse after discharge from the ED. Methods: This a randomised, double-blind, placebo-controlled clinical trial among all children 8 to 17 years of age with a presumptive diagnosis of acute migraine and treated with a standardized protocol in the ED of the CHU Ste-Justine, a tertiary care pediatric hospital. After the parenteral administration of prochlorperazine or metoclopramide and diphenhydramine, the patients were randomised to receive either dexamethasone or a placebo. They were excluded from the intervention if they had a known allergy or absolute contraindications to receiving parenteral corticosteroids, if they were already on a corticosteroid regimen or if they did not respond to the initial abortive migraine therapy. All included patients were discharged on a 48-hour course of naproxen and with a headache diary to fill out and return. The primary outcome was the incidence of relapse in the 24-48h following discharge from ED. The secondary outcomes evaluated were the mean level of pain, the use of rescue medication after ED discharge, the return rate to the ED or the visit to a health care professional within 7 days including hospitalisation. The associated symptoms, the adverse events after parenteral corticosteroids and the risk factors for migraine relapse were also evaluated. A telephone follow-up was made to ensure the headache diary was completed and returned.

Start: May 2014

Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab

To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.

Start: October 2020

The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients

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.

Start: July 2020