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Migraine With Aura clinical trials

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NCT ID: NCT06267664 Recruiting - Migraine Clinical Trials

Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP)

TRIDIGEP
Start date: December 4, 2023
Phase:
Study type: Observational [Patient Registry]

Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs. The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study. This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors. The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes.

NCT ID: NCT06244823 Recruiting - Migraine Disorders Clinical Trials

The FreMRI Study: Advanced MRI on Migraine Patients Treated With Fremanezumab

FreMRI
Start date: March 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this open-label, single-blind, controlled-trial is to evaluate brain changes evaluated with diffusion Magnetic Resonance Imaging (MRI) and functional MRI in patients with high-frequency episodic migraine and chronic migraine that will be treated with Fremanezumab, 12 weeks after the treatment onset, compared with the baseline. Type of study: Phase IV clinical trial Participant population: high-frequency episodic migraine and chronic migraine. Participants will be treated with Fremanezumab.

NCT ID: NCT06051604 Recruiting - Migraine Clinical Trials

Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

This is a prospective, double-blind, sham-controlled, randomized two-part clinical trial with an adaptive design. This study aims to assess the efficacy, safety, tolerability, and the optimal dose of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting. This study will be conducted in two parts. The first part of this study aims to determine the most effective dose of Mi-Helper and the second part aims to evaluate the efficacy, safety, and tolerability of the most effective dose of the Mi-Helper device for the acute treatment of episodic migraine in adults. Adults aged 18 years to 65 years old with a diagnosis of episodic migraine (with or without aura) for at least one year (self-reported) will be recruited for this study.

NCT ID: NCT06046508 Recruiting - Migraine Headache Clinical Trials

Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)

MANET
Start date: May 18, 2023
Phase:
Study type: Observational

This is a multicenter prospective observational study aimed to asses whether a specific prothrombotic platelet phenotype can discern migraine patients with PFO (patent forame ovale) - related symptoms from patients with incidental PFO. The study will also explore additional distinguishing features of causal and incidental PFO using a metabolomics approach. It involves the enrollment of well-characterized patient cohorts and an ex vivo approach using comparative cell biology models that reproduce the most critical aspects of the clinical scenario.

NCT ID: NCT06023953 Completed - Clinical trials for Migraine Without Aura

Migraine With and Without Aura Response to Remote Electrical Neuromodulation (REN) Treatment

Start date: July 1, 2023
Phase:
Study type: Observational

This is a Post-marketing study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura. Safety will be assessed by the number and type of device-related adverse events. Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment. Disease characteristics will look into demographic and attack differences between patients with and without aura.

NCT ID: NCT05903040 Recruiting - Migraine Clinical Trials

Ditan Acute tReatments: Effectiveness and Tolerability (DART)

DART
Start date: June 15, 2023
Phase:
Study type: Observational

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of lasmiditan as acute migraine treatment in a cohort of episodic or chronic migraine patients.

NCT ID: NCT05903027 Recruiting - Migraine Clinical Trials

Gepant treAtments: EffectIveNess and tolERability (GAINER)

GAINER
Start date: June 15, 2023
Phase:
Study type: Observational

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as acute migraine treatment in a cohort of episodic or chronic migraine patients.

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: NCT05679908 Completed - Chronic Migraine Clinical Trials

A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

PREVENTION
Start date: December 6, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 IU daily and 60 IU daily) of TNX-1900 in patients with chronic migraine.

NCT ID: NCT05617339 Not yet recruiting - Clinical trials for Migraine Without Aura

Tailored Digital Treatment for Migraine

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Background: An individualized internet-based treatment program from a biopsychosocial perspective has been developed within the Västra Götaland region (VGR) with funds from the Innovation Fund. The treatment program is called Learn to live with migraine and goes by the abbreviation I AM (Internet Approach to Migraine). I AM is a complement to the medical treatment and focuses on pain management and learning to live as good a life as possible with the disease migraine. During the spring of 2022, I AM has been tested regarding the feasibility of primary care on 29 research subjects in a pilot RCT (DNR 2020-02359). A weighted preliminary assessment shows moderate effect size on mental health, that the participants accept the intervention, and that I AM with recruitment and care process can be carried out in a primary care context. Purpose: An overall purpose of the study is to evaluate the effect of the addition of the internet-based biopsychosocial treatment I AM compared to usual treatment (TREATMENT as usual - TAU) in primary care regarding frequency and severity of migraine attacks, functional level, mental health, quality of life and employment rate with a randomized controlled trial design (RCT). An additional aim is to evaluate whether it is possible to prevent episodic migraine from developing into chronic migraine among those who have episodic migraine at the start of the study via the supplement treatment program I AM. Expected results: The greatest expected benefit of I AM is to reduce the burden and suffering of migraines for all the people affected. AM is also expected to increase the availability of treatment with a biopsychosocial perspective, have a quality-enhancing effect in terms of method and increase the patient's participation in their treatment. An environmental aspect is that neither patient nor therapist need to travel, accessibility also increases for individuals living in smaller communities who receive equal treatment.