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Migraine Disorders clinical trials

View clinical trials related to Migraine Disorders.

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NCT ID: NCT04693533 Recruiting - Sleep Disorder Clinical Trials

Fremanezumab, Migraine and Sleep

Start date: July 29, 2021
Phase: Phase 4
Study type: Interventional

The main goal of this study is to determine whether there is a relationship between fremanezumab's ability to prevent migraine and improved sleep quality in migraine patients (fremanezumab is a FDA-approved humanized CGRP monoclonal antibody for the treatment of migraine). This is a within-person study design that examines treatment effects (changes) using high-resolution assessments. To complete the study, each participant will be observed using daily assessments of migraine and sleep outcomes before treatment (baseline: 0 to 30 days), and at 1, 2, and 3 months after treatment (injection 1: days 31-60, injection 2: days 61-90, injection 3: days 91-120). In essence, this creates an interrupted time-series design where repeated interventions are introduced at fixed intervals.

NCT ID: NCT04674020 Recruiting - Migraine Clinical Trials

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

REFORM
Start date: October 22, 2020
Phase: Phase 4
Study type: Interventional

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

NCT ID: NCT04649242 Recruiting - Pediatric Migraine Clinical Trials

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Start date: January 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

NCT ID: NCT04628429 Recruiting - Chronic Migraine Clinical Trials

CGRP Inhibition, Autonomic Function, and Migraine

CGRP-1
Start date: October 1, 2020
Phase:
Study type: Observational

The purpose of this clinical study is to better understand the function of the autonomic nervous system in patients with migraine. We aim to understand whether the autonomic functions change depending on the migraine status (i.e. whether they are between or during attacks) and whether the CGRP monoclonal antibody (mAb) class of drugs affects the autonomic functions. The aim is not to investigate the effect of CGRP-mAb on migraine frequency. Calcitonin gene-related peptide (CGRP) is a neurotransmitter in the nervous system that plays an essential role in the development of migraine headache. Monoclonal antibodies can block the function of this messenger substance. Several studies have shown that this blockade leads to a reduction in the frequency of migraine. In addition to its role in migraine, CGRP also acts on the blood vessels and the autonomic nervous system. The autonomic nervous system is responsible for everything we have no control over in our body. This includes everything from heart rate and blood pressure to our digestion.

NCT ID: NCT04623203 Recruiting - Children, Only Clinical Trials

The Prognosis of Migraine and Tension-Type Headache in Children and Adolescents

Start date: November 22, 2018
Phase:
Study type: Observational [Patient Registry]

Children and adolescents that visited the pediatric neurology clinic at the Bnai Zion medical center do to migraine or TTH headache between the years 2007-2010 were reevaluated. We used a structured headache questionnaire through a phone interview with the patients and their caregivers. Data regarding demographics, the patients' and families' medical history, and headache history, past and current (age at onset, location, quality, frequency, duration of episodes, aura, associated symptoms and treatment) were collected.

NCT ID: NCT04616326 Recruiting - Chronic Migraine Clinical Trials

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

REBUILD-2
Start date: November 25, 2020
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

NCT ID: NCT04607460 Recruiting - Migraine Clinical Trials

EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines

BEAT-Pain
Start date: December 3, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04603976 Recruiting - Migraine Clinical Trials

Registry for Migraine - Clinical Core

REFORM
Start date: September 25, 2020
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04592952 Recruiting - Migraine Clinical Trials

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

Start date: October 8, 2020
Phase: Phase 4
Study type: Interventional

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

NCT ID: NCT04567355 Recruiting - Migraine Clinical Trials

Migraine Manager (R01)

Start date: June 10, 2021
Phase: Phase 2
Study type: Interventional

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.