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101 active trials for Migraine

A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

The primary objective is to evaluate the efficacy of monthly 225 mg sc fremanezumab in adult patients with migraine and major depressive disorder (MDD) The secondary objectives are to evaluate the efficacy of monthly 225 mg sc of fremanezumab in adult patients with migraine and MDD on the reduction of MDD symptoms, responder rates in monthly migraine days, improving quality of life, improving disability, and the safety and tolerability of monthly 225 mg sc and quarterly 675 mg sc fremanezumab in adult patients with migraine and MDD. The total duration of patient participation in the study is planned to be approximately 28 weeks.

Start: September 2019

Decoding Pain Sensitivity in Migraine With Multimodal Brainstem-based Neurosignature

Migraine is a highly prevalent and disabling neurological disease, which has a tremendous impact on sufferers, healthcare systems, and the economy. According to the 2016 WHO report, migraine is the second leading cause of years lived with disability, greater than all other neurological diseases combined. Yet, the treatment in migraine is far from optimum; the sufferers often abuse painkillers and complicated with medication overuse headache. Migraine is characterized by the hypersensitivity of the sensory system, potentially attributed to dysfunctional pain modulatory networks located in the deep brain structures, particularly the brainstem. However, the current understanding of these deeply seated, dysregulated pain modulatory circuits in migraine is limited due to technological constraints. Besides, studies with an in-depth analysis of the clinical manifestations (i.e., deep phenotyping) are lacking, and there is no corresponding animal model readily available for translational research. In this project, the investigators propose a multimodal approach to address these issues by applying the technologies and platforms developed by our team to explore the correlation between pain sensitivity and dysregulated connectivities from brainstem to other brain regions. In this four-year project, the investigators will recruit 400 migraine patients and 200 healthy subjects. The investigators aim at decomposing the key brainstem mechanisms underlying dysmodulated pain sensitivity in migraine from 5 comprehensive perspectives: (1) clinical deep phenotyping, (2) high-resolution brainstem structural MRI and functional connectivity analysis, (3) innovative brainstem EEG signal detecting technique, (4) multimodal data fusion platform with neural network analysis, and (5) ultrahigh-resolution brainstem-based connectomes, intravital manipulations and recording, and connectome-sequencing in animal models. Moreover, the investigators will collaborate with Taiwan Semiconductor Research Institute to develop a wearable high-density EEG equipment, integrated with a System-on-Chip capable of edge-computing the signal using algorithms derived from our brainstem decoding platform. The ultimate goal is to build a real-time brainstem decoding system for clinical application.

Start: February 2021

Effectiveness of Gaze Stability Exercises on Balance and Activities of Daily Living Among Patients Suffering Vertigo With Vestibular Neuritis in Saudi Arabia

Gaze stability exercise is a medical procedure for persons with unilateral vestibular disturbances such as vestibular neuritis or persons who have had tumors of their 8th nerve. They are a crucial part of the vestibular dysfunction rehabilitation protocols in health centers. These activities which involve turning one's eyes at different angles while having their eyes focused on an optotype are aimed at helping improve the vestibular ocular reflex (VOR), visual acuity during head movements and also reducing vertigo and dizziness. Study aim: This review will be establishing the effectiveness of applying gaze stability with balance exercises procedure among participants who are suffering vertigo due to vestibular neuritis. Methods: Twenty volunteers between the age of 25-59 years old, diagnosed, and confirmed to be suffering from vestibular neuritis and vertigo will be used in this study. Gaze stability exercises will be performed while patients are in a seated position. Each exercise will last for 30 seconds and be done in phases that included; eyeball movement, saccadic eye movement, pursuit eye movement, vergence eye movement, and vestibular-ocular reflex exercise. Balance exercises will be performed in a standing position including both static and dynamic training with or without closing eyes. The following outcome measures for each participant will be assessed pre-and post-treatment after completing four weeks of intervention. They include; Arabic version of Activities-Specific Balance Confidence Scale (A-ABC scale), Arabic version of Dizziness Handicap Inventory (A-DHI), Berg Balance Scale (BBS), and Katz Index of Independence in Activities of Daily Living (Katz ADL). The findings will then be subjected to statistical methods and data analysis using the SPSS toolkit. In this study we hypothesis that practicing gaze stability and balance exercises will have a positive influence on balance and activities of daily living among vestibular neuritis patients.

Start: February 2021

Narrow Band Green Light and Migraine

Study volunteers are asked to use the Allay Lamp routinely during the 6-week study period. A web based survey is provided when the Lamp is purchased for study volunteers to complete. A daily usage paper diary is sent with the lamp so that volunteers can keep track of the frequency and duration of lamp usage and any noticeable benefits. At the end of six weeks a second survey is sent to study volunteers to capture their perceptions of potential lamp benefits with respect to headache frequency and their experience of migraine specific symptoms.

Start: December 2020

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Migraine Headaches

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Start: March 2020

A Study of LY3451838 in Participants With Migraine

The reason for this study is to see if the study drug LY3451838 is safe and effective in participants who have migraine that have not responded to other preventive treatments.

Start: November 2020

A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

Start: March 2021

Identification of Endometriosis and Migraine Criteria in Women With the Comorbidity of Both Conditions in Comparison With Women Who Only Suffer From Endometriosis - A Pilot Study

Patients with both, migraine and endometriosis, present the case-group, while women with endometriosis without migraine serve as controls. The primary endpoint is endometriosis stage confirmed by laparascopy compared to the control group. Further points to compare between groups are infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations, family history with first-degree relatives, and age of first symptoms for both conditions and age at first operation. Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response, response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted. In the questionnaire we will ask 62 Questions overall. The Questions for endometriosis are based on a questionnaire from the world endometriosis research foundation and to evaluate the severity of the migraine we will use the MIDAS (Migraine Disability Assessment) questionnaire (8).

Start: April 2021

Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.

Headaches are more common in the month of Ramadan in patients who already suffer from migraine. The object of the present study is investigate the frequency in the Ramadan month .

Start: March 2021

Observational Study on the Efficacy, Safety, and Tolerability of GAlcanezumab in Real Life Migraine Patients in ITaly

Objective: To determine in real life the efficacy, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic (CM) migraine. Design: This prospective observational cohort study was conducted between November 2019 and January 2021. Participants: Consecutive adult HFEM and CM patients clinically prescribed galcanezumab were enrolled. Setting: Multicenter study in 13 Italian headache centers. Exposure: Galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg. Main Outcome(s) and Measure(s): The primary end-point was the change in monthly migraine days (MMDs) in HFEM patients and monthly headache days (MHDs) in CM ones after six months of therapy (V6) compared to baseline. Secondary end-points included variation in Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6, and MIDAS scores. We assessed 50%, 75%, and 100% responder rates (RR), the conversion rate from CM to episodic migraine (EM), and the Medication Overuse condition to the non-overuser.

Start: November 2019

Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study

The aim of the study is to evaluate the effect of self-administered intranasal cooling for the symptomatic relief of migraine headache and associated symptoms in an "at home setting". 10-20 patients - who have been diagnosed according to the International Classification of Headache disorders (2nd Edition) criteria for Episodic migraine, with or without aura - will be included in the study. During a screening period of one month participants will record their migraine symptoms, any treatment and treatment effects. After a minimum om two migraine attacks the participants receive individual instructions on how to use the The RhinoChill® system. During the following treatment period of the study, participants are instructed to treat their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24 hours and 48 hours.

Start: March 2021

Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Researchers are trying to find out more about the side effects of fremanezumab when treating patients with Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) for migraine headaches.

Start: December 2021

Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine

The purpose of this study is to illustrate the safety and effectiveness of the StimRelieve Halo Nerve Stimulator System in the treatment of chronic migraine. The StimRelieve Halo System utilizes a minimally invasive procedure to implant a neurostimulator. This technology includes an octopolar electrode array stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The StimRelieve Halo System eliminates the implantable pulse generator, which has been the most common reason for reoperation or discomfort with existing devices. For this study, all subjects will be randomized at enrollment into either a delayed or immediate continuation group. The immediate continuation group will immediately continue with the stimulation therapy after the 30-day trial period and will be monitored for a total of 12 months. The delayed activation group will have their device turned off after the 30-day trial period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed activation group will have their devices reactivated. All subjects will immediately receive the permanent stimulator(s). The permanent stimulators can easily be removed if non-responders are identified. The wireless technology eliminates the need for externalized extensions, IPG's and thus reoperation. Additionally the outcome is highly dependent on placement of the stimulators. By eliminating the need for a staged trial, infection rates and incidence of pocket pain will decrease. In this study, subjects will undergo a 30-day trial in order to demonstrate effectiveness. Immediate activation of all devices will be done in the post-op period based on sensory response and subject comfort. Subjects will be seen at 14-days post-implant to assess patient compliance with the device, assess clinical response and to adjust programming parameters if not responding. Subjects will be seen at 1 month post-implant and headache diaries and questionnaires will be reviewed. Subjects not responding to the therapy by at least a 30% reduction in headache days will be deemed non-responders and will be withdrawn from the study and can choose to have the device removed. After the trial period, all responders will follow their random assignment determined at enrollment (delayed or immediate continuation). All subjects will be monitored for a total of 13 months. Adverse events will be monitored throughout the study.

Start: December 2022

Human Electrophysiological Model to Quantify the CGRP-related Axon Reflex of Trigeminal Afferents

The proposed project aims at establishing Calcitonin gene-related peptide (CGRP)-Related Axon Reflex of Trigeminal Afferents as a neurophysiological biomarker for migraine.

Start: February 2021

Eptinezumab in Adults With Migraine and Medication Overuse Headache

This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache

Start: February 2021

Investigation and Modulation of the Mu-Opioid Mechanisms in Migraine (in Vivo)

This study investigates whether non-invasive brain stimulation, given for 20 minutes/once per day for ten days (M-F) can reduce migraine pain. Thirty patients will receive this treatment, while thirty will receive a "sham" procedure. Up to thirty healthy volunteers will be asked to undergo baseline assessments only (imaging, but no brain stimulation). Healthy volunteer data may be used from a prior study (NINDS-K23062946 project [IRBMED #HUM00027383; Dr. Alexandre DaSilva, Principal Investigator]).

Start: February 2017

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study

Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

Start: February 2021

Objectively Diagnose and Monitor Treatment of Light Sensitivity

The purpose of this project is to provide a new framework for diagnosing and monitoring treatment of light sensitivity and headache by objective measurement of facial features, pupil responses, retinal electrical responses and autonomic nerve responses to light.

Start: July 2019

Oral Contraceptive Pill Compared With Vitamin E in Women With Migraine

Open-label randomized controlled trial to study the efficacy of continuous daily use of ethinylestradiol/levonorgestrel (30/150 µg/day) compared with vitamin E (400 IU/day) in the treatment of women with menstrually-related and perimenopausal migraine.

Start: September 2019

Omega-3 Fatty Acid in the Prevention of Migraine

To understand the clinical efficacy for omega-3 PUFAs migraine prevention.To uncover the underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine prevention.

Start: December 2020