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Migraine clinical trials

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NCT ID: NCT05164172 Recruiting - Migraine Clinical Trials

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

REJOIN
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

NCT ID: NCT05161871 Recruiting - Migraine Clinical Trials

Transcranial Direct Current Stimulation Plus Monoclonal Antibodies Acting on the CGRP Pathway for Migraine

Start date: May 16, 2022
Phase: N/A
Study type: Interventional

Electrophysiological changes that occur in the brains of migraine patients, lead to the activation of nociceptive centers, including a peripheral neural structure, the trigeminal ganglion (TG), which releases pain-inducing peptides and mostly calcitonin gene-related peptide (CGRP). Monoclonal antibodies acting on the CGRP pathway (CGRP-MAbs) are the first drugs specifically designed for migraine, they inhibit CGRP release from the TG without entering the brain. Not all patients experience benefit from CGRP-MAbs treatment. For this reason, associating these drugs with a non-pharmacological treatment that acts centrally, such as transcranial direct current stimulation, could be effective. The aim of the study is investigating how the migraine preventive treatment with CGRP-MAbs in association with tDCS, is effective to reduce headache days, days of disabling headache, intensity of pain and consumption of acute treatments. Migraine-related disability, quality of life, sleep disturbance and psychological aspects will also be evaluated. Patients will be randomized into two groups, one will receive active tDCS and one sham tDCS. Both patients and investigators will be blind to the treatment administered (double-blind). Furthermore, will be evalutated the cortical mechanisms involved in migraine by directly modulating brain physiology via repetitive tDCS in patients with migraine on treatment with CGRP-MAbs. To fulfill this aim, we will assess the EEG correlates of the actual effects of the stimulation in a sham-controlled study, providing the EEG indexes linked to the altered and potentially restored cortical dynamics in migraine.

NCT ID: NCT05158894 Recruiting - Migraine Clinical Trials

Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy

Start date: January 10, 2023
Phase:
Study type: Observational

Migraine is a common neurological disorder typically characterized by attacks of throbbing or pulsating headache on one side of the head of moderate to severe pain intensity. The purpose of this study is to evaluate fetal, maternal, and infant outcomes through 12 months of age among women exposed to Ubrelvy or Qulipta during pregnancy, as well as in 2 comparator groups. Ubrelvy (ubrogepant) and Qulipta (atogepant) are approved drugs for the acute treatment of migraine in adults. Approximately 628 pregnant women with migraine exposed to Ubrelvy, 628 pregnant women with migraine exposed to Qulipta and 628 pregnant women with migraine in comparator group will be enrolled in this study in the United States. Participants enrolled in the Ubrelvy-exposed group and Qulipta-exposed group will receive Ubrelvy and Qulipta respectively as prescribed by their physician.

NCT ID: NCT05156398 Recruiting - Migraine Clinical Trials

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

Start date: February 28, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.

NCT ID: NCT05125302 Recruiting - Migraine Clinical Trials

Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)

Start date: January 13, 2022
Phase: Phase 3
Study type: Interventional

Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, 2 to 24 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. 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 effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05086562 Recruiting - Migraine Clinical Trials

Prevalence of Chronic Abdominal Pain in Migraneurs

Start date: September 1, 2021
Phase:
Study type: Observational

To collect data on the prevalence of Chronic Abdominal Pain in Migraneurs in Germany

NCT ID: NCT05046613 Recruiting - Migraine Clinical Trials

Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant

MONITOR
Start date: November 3, 2021
Phase:
Study type: Observational

The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

NCT ID: NCT05042037 Recruiting - Migraine Clinical Trials

Probiotics as Adjunctive Migraine Prophylaxis

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

This study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine

NCT ID: NCT04946734 Recruiting - Migraine Clinical Trials

Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine

SPRING
Start date: August 12, 2021
Phase: Phase 3
Study type: Interventional

Effectivity and safety of PFO closure vs medicine in alleviating migraine (SPRING): a multicenter, random, case control study

NCT ID: NCT04939922 Recruiting - Fibromyalgia Clinical Trials

China Headache Registry Study

CHRS
Start date: June 12, 2017
Phase:
Study type: Observational [Patient Registry]

In the Chinese Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned.