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Migraine clinical trials

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NCT ID: NCT05891808 Recruiting - Pain Clinical Trials

miR-155 Expression in Episodic and Chronic Migraine

Start date: September 22, 2020
Phase:
Study type: Observational

Migraine is a common, yet often disabling, neurological disease that affects over 1 billion people around the world. It's the second most disabling disease globally and the leading cause of disability for people under the age of 50, especially women. The effects of migraine aren't limited to the individual, with a tremendous economic impact on families, friends, and employers. To help reduce this burden, research is now focusing on developing biomarkers that can help with diagnosis, predicting response to treatments, and identifying those at risk of developing chronic migraine. MicroRNAs (miRNAs) are one of the most promising classes, as they can modulate gene expression and affect a wide range of cellular processes. Other studies have already observed different miRNA expression in those with episodic migraine or chronic migraine, but no specific miRNAs have been identified as a strong and specific migraine signature. miRNA-155 is of particular interest, as it has been linked to inflammation and pain, and may be a potential target for migraine treatments. It is known that the immune system plays a role in migraine headaches. Monocytes, a type of immune cell, may be involved in the development of migraines. Certain medicines, such as aspirin, can affect monocyte function and have been used to treat migraines. Recent research has also shown that microRNAs can regulate the activity of these cells and influence inflammation, which may be linked to migraine attacks. This study aims to investigate the role of miRNA-155 and monocyte differentiation in migraine patients, and in particular its association with migraine phenotype and severity. We aim to study three groups of subjects: Episodic migraine (EM), Chronic migraine with or without Medication Overuse Headache (CM-MOH) and Healthy Controls (HCs).

NCT ID: NCT05889624 Recruiting - Migraine Clinical Trials

Responding With Evidence and Access for Childhood Headaches

Start date: August 22, 2023
Phase: N/A
Study type: Interventional

This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.

NCT ID: NCT05861427 Recruiting - Migraine Clinical Trials

Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

Release
Start date: July 12, 2023
Phase: Phase 3
Study type: Interventional

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

NCT ID: NCT05827887 Recruiting - Migraine Clinical Trials

An Observational Study to Assess Ubrogepant Tablets and Atogepant Tablets to Treat Migraine in Adult Participants

COBRA
Start date: June 25, 2023
Phase:
Study type: Observational

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate how effective the use of ubrogepant and atogepant is in treating adult participants with migraine. Urogepant (Ubrelvy) and Atogepant (Qulipta) are approved drugs for treatment of migraine in adults in the US. Approximately 200 adult participants who are prescribed Ubrogepant or atogepant by their doctors will be enrolled in this study in Israel. Participants will receive ubrogepant oral tablets or atogepant oral tablets as prescribed by their physician. Participants will be followed for 90 days. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

NCT ID: NCT05810038 Recruiting - Migraine Clinical Trials

A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.

Start date: May 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the effects of Rimegepant to help prevent migraine. This study is seeking for participants who: - Are male and female of 18 years of age or older. - Have at least 1 year history of migraine . - Did not take any medication for migraine before the start of this study. The study will go on for around 30 weeks, including 4 Phases and 11 Visits. Participants who are selected for the study will be randomly assigned to treatment groups. After which, the participants will enter a 12-week Double-blind Treatment (DBT) Phase. After finishing the DBT Phase, some selected participants may enter a 12-week Open-label Extension (OLE) Phase. Participants will come back to the study site at the end of Week 24 for the End of Treatment (EOT) Visit. There will be a follow-up Week 2 Visit around 14 days after the EOT visit. Participants will be asked to take 1 tablet of study medicine every other calendar day. This need to be followed regardless of whether they have a migraine on that day or not. During the OLE Phase only, if a participant has a migraine on a non-scheduled dosing day, they may take 1 tablet of Rimegepant orally disintegrating tablet (ODT) as acute treatment for their migraine, if needed, with a maximum of 1 tablet of Rimegepant per calendar day. The study team will look at how each participant is doing with the study treatment during the regular visits at the study clinic.

NCT ID: NCT05785988 Recruiting - Migraine Clinical Trials

Anti-CGRP Monoclonal Antibody Response After Switching (AMARAS)

AMARAS
Start date: November 1, 2019
Phase:
Study type: Observational

Monoclonal antibodies targeting calcitonin gene-related peptide (mAb-CGRP) have shown efficacy and effectiveness in the treatment of episodic and chronic migraine, however, not all patients respond to them. Preliminary data suggests that some patients who failed to one of them, may respond to a different anti-CGRP monoclonal antibody. Observational analytic study with a retrospective cohort design including patients treated with a second mAb-CGRP due to lack of response to the first one. The aim of this study is to provide Class II evidence about the effectiveness and tolerability of the mAb-CGRP switching in patients with migraine, treated in a real-world setting.

NCT ID: NCT05768828 Recruiting - Migraine Clinical Trials

Stimulation-evoked Calcitonin Gene-Related Peptide (CGRP) as Biomarker of Migraine

Start date: February 20, 2023
Phase:
Study type: Observational

This study aims to improve the management migraine by providing a more profound understanding of the interactions of pain disinhibition on the brain stem level and calcitonin gene-related peptide as a main mediator in the generation of migraine headaches. For this purpose, this observational study investigates established neurophysiological and blood biomarkers parameters in association with the clinical phenotype.

NCT ID: NCT05752396 Recruiting - Healthy Volunteers Clinical Trials

Overlapping Pain Trajectory Study

COPC
Start date: March 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1. If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls. 2. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth. Participation includes: - quantitative sensory testing - blood draw - sleep assessment - questionnaires

NCT ID: NCT05748483 Recruiting - Migraine Clinical Trials

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

TEMPLE
Start date: October 7, 2023
Phase: Phase 3
Study type: Interventional

A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

NCT ID: NCT05741775 Recruiting - Migraine Clinical Trials

Physiotherapy Intervention for Migraine Symptoms

Start date: September 18, 2022
Phase: Early Phase 1
Study type: Interventional

The goal of this randomized control trial is to analyse the effectiveness of Physiotherapy intervention among university students with migraine symptoms. The main objective is: 1. To determine the effect of aerobic exercise on the resting-state brainwaves among university students in UTAR with migraine symptoms compared with biofeedback and control exercise. 2. To analyse the influence of aerobic exercise on the sleep quality and quality of life among the cohort compared with biofeedback and control exercise. Although the Migraine Research Foundation listed three main types of non-drug treatments for migraine are lifestyle advice, therapies, and exercises. Some common aerobic exercises such as walking, jogging, a behavioral weight loss program, cycling, and a combination of cross-training, walking, jogging, and cycling are suggested to be beneficial to the migraine patients but there remains no specific protocol established till now. Hence the other main objective of this is to establish a aerobic exercise protocol for patients with migraine symptoms.