Clinical Trials Logo

Migraine clinical trials

View clinical trials related to Migraine.

Filter by:

NCT ID: NCT05162664 Completed - Migraine Clinical Trials

Presence of Signs of Central Sensitization in Episodic and Chronic Migraine

CENSENMI
Start date: October 15, 2021
Phase: N/A
Study type: Interventional

Nowadays migraine is conceptualized as a continuum, with at the one hand episodic migraine (EM) and at the other hand chronic migraine (CM) (1). The general aim of the study is to determine where exactly in this continuum central sensitization (CS) appears. Recent studies support the presence of CS in migraine patients (2,3), but controversial evidence exists about where in the continuum exactly CS appears. Some studies determined no differences in sings of CS between EM and CM (4,5), whether other research indicate a clear difference between EM and CM (6-8). However a significant difference in CS parameters could be determined between a patient group (EM or CM) and a healthy control group (3,4,8). In addition, CS appears to be present during the migraine attack (2). In this research, the presence of signs of CS will be determined in between headache phases. The primary outcome measure is identification of CS by PPT, QST, TS, CPM and CSI. Secondary outcome measures are the outcome of the MIDAS, HADS and EUROLIGHT.

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: NCT05133323 Completed - Migraine Clinical Trials

A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

Start date: November 11, 2021
Phase: Phase 2
Study type: Interventional

Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines. People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them. When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.

NCT ID: NCT05127954 Enrolling by invitation - Migraine Clinical Trials

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)

Start date: January 14, 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 long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 120 sites in the United States. Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks. 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: NCT05127486 Completed - Migraine Clinical Trials

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

CHALLENGE-MIG
Start date: December 6, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.

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: NCT05112289 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study to Evaluate White Matter Hyperintensities in Migraine

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraines

NCT ID: NCT05101837 Not yet recruiting - Migraine Clinical Trials

Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions

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

A standardized behavioural approach based on mindfulness delivered mainly by a specific APP on android will be developed and applied for patients with chronic pain conditions, as migraine and neuropathic pain. The aim of this pilot study: The investigators propose a pilot study to enforce the application of a Home-program for patients with different pain conditions, to learn mindfulness practice, added to a regular mindfulness guided face-to-face program, by using the technology with android to receive mindfulness sessions for daily practice and to assess the feasibility and the effectiveness of behavioural approach base on mindfulness delivered with this modality.