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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: 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: NCT05565001 Recruiting - Headache Clinical Trials

The Involvement of ATP Sensitive Potassium Channel in Migraine Aura and Migraine Pain.

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The aim of the present study to investigate whether - Opening of KATP channels causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways. - Opening of KATP channels causes migraine aura by induction of CSD.

NCT ID: NCT05546385 Recruiting - Migraine With Aura Clinical Trials

PArtial REbreathing for Migraine With Aura 1

PAREMA1
Start date: June 16, 2023
Phase: N/A
Study type: Interventional

A prospective, multi-centre, randomized, double-blind, sham-controlled, parallel-group, group-sequential study to investigate safety and effectiveness of the Rehaler partial rebreathing device, in adults suffering from migraine with aura

NCT ID: NCT05516251 Recruiting - Migraine, Classic Clinical Trials

Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Migraine has been ranked as the second most disabling neurological disorder in the worldwide. Medication or nonpharmacological treatments are all reasonable options for the prevention. Oral topiramate treatment is a typical effective method, while transcutaneous supraorbital nerve stimulation (SNS) was reported to be valuable for migraine acute treatment and even the prevention. As a new nonpharmacological therapeutic method, whether SNS is equivalent to topiramate is still unknown. The aim of the present study was to compare their effects in a cohort of migraine patients. After diagnosed with recurrent or chronic migraine and consented to this research, patients received randomly treatments by either SNS or topiramate, and were followed up prospectively. After a 1-month period of baseline observation, patients were followed by a 1-month treatment, and next 2-month period of followup. At least the following assessments will be performed: (1) Change from baseline in the number of migraine days during the 3 observing months; (2) Change from baseline in the number of moderate/ severe headache days over the 3 observing months; (3) 50% responder rate for the reduction of migraine days (percentage of patients having at least 50% reduction of migraine days) during the first treating month. Comparison of outcome measures between the 2 treatment groups will be performed to show the equivalence of SNS versus topiramate.