Clinical Research Directory

Zonisamide Versus Topiramate in Migraine

Investigators aim to compare the effect of zonisamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency

Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly. Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world. All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24). There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.

Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice. Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea. Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

The main purpose of this study is to evaluate the effectiveness of a new treatment in improving chronic migraine symptoms. This treatment involves a targeted lidocaine infusion into blood vessels in the skull to numb pain receptors, potentially leading to improvements in chronic migraine intensity, frequency, and duration.

A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

This study is a single-arm, prospective, multicenter, observational registry study. It plans to enroll 120 migraine patients who meet the inclusion criteria and are treated with rimegepant in selected hospital outpatient clinics in the Greater Bay Area. The main purpose of this study is to observe the effectiveness of rimegepant in treating migraines in a real-world clinical setting, including the impact of rimegepant on the quality of life, functioning, productivity status of migraine patients, and patients' satisfaction with the use of rimegepant in treating migraines.

Basic Body Awareness Therapy in Individuals With Migraine

One biopsychosocial approach proven effective in headache treatment is basic body awareness therapy. This study was planned to evaluate the effectiveness of basic body awareness training and lifestyle recommendations in individuals diagnosed with migraine. Functional status will be assessed using the Migraine-Related Disability Assessment Scale (MIDAS), sleep quality using the Jenkins Sleep Scale (JUS), and quality of life using the Headache Impact Test. Assessment of functional status, sleep quality, and quality of life will be performed before treatment and after treatment (at the end of week 8).

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks. Rimegepant is a tablet that dissolves when you put it on or under your tongue. The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day. Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months. In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period. Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.

A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults

The purpose of this study is to assess the bioequivalence of an alternative ODT formulation (ODT2) versus the approved ODT formulation of a CGRP receptor antagonist in healthy adult participants under fasting conditions.

Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

This goal of this study is to compare three medications used for migraine preventive treatment. This study will compare atogepant, a newer migraine preventive medication, with two older preventive medications, topiramate and propranolol. It will be determined if one works better and is more tolerable than the others. Research participants will: * Be randomly assigned to one of the three medications. * Provide information about their migraine pattern using a daily headache diary and during research visits.

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

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.

BIOMIGA: Results From Magnetic Resonance Imaging

The projects comprising in the multicenter BIOMIGA project have been preregistered earlier with ID NTC04503083 at clinicaltrials.gov. Here the imaging subproject within the overall BIOMIGA aims is specified. The hypotheses for this subproject of the magnetic resonance imaging part is based on hypotheses generating analyses of the data from one site (Hamburg, Germany) of this three-center study. At all three sites healthy controls and migraine patients underwent identical protocols with 3 types of magnetic resonance imaging including structural scans (MPRAGE), resting-state functional magnetic resonance imaging (rs-fMRI) as well as arterial spin labeling (ASL) with matched protocols across sites. Data was acquired before CGRP-antibody administration (day 1) and 12 weeks afterwards (day 2). We analyzed the data from one site (Hamburg, Germany) as hypotheses generating, published these data as a poster and aim to validate our results with the not-yet analyzed data from the two other sites (Pavia, Italy and Barcelona, Spain).

Common Pain Mechanisms in Migraine, Migraine-Related Neck Pain, and Lower Back Pain: A Cross Sectional Study

Migraine is one of the primary headache disorders with a high prevalence worldwide, leading to significant disability and reduced quality of life. Trigeminal nerve activation and alterations in central pain processing mechanisms play a crucial role in the pathophysiology of migraine. Recent studies suggest that migraine may not only be a headache disorder but also a systemic pain disorder associated with changes in central pain processing mechanisms. Central sensitization is defined as increased sensitivity of nociceptive neurons in the central nervous system to afferent stimuli and is considered a key mechanism in the development and maintenance of chronic pain conditions. This condition is characterized by pain hypersensitivity, allodynia, and generalized pain sensitivity. In addition to headaches, other musculoskeletal pains are also frequently reported in migraine patients. Spinal pain, particularly neck and lower back pain, can occur in migraine sufferers, with central sensitization contributing to the condition, considering the spine as a chain. Large population-based studies have shown a significant association between primary headaches and persistent low back pain, and a higher prevalence of concomitant low back pain has been reported in individuals with chronic migraine and chronic tension-type headaches. This association is suggested to be explained by the shared nociceptive pathways of the head and spinal structures and the changes in central pain processing seen in chronic pain conditions. This relationship between migraine and musculoskeletal pain is also explained by the presence of shared neuroanatomical structures such as the trigemino-cervical complex. Nociceptive afferents from the upper cervical spine and cranial structures converge at the trigemino-cervical complex level in the brainstem, creating a predisposition to the co-occurrence of head and neck pain. This mechanism suggests that pain or dysfunction in the cervical region in migraine patients may be related to headache symptoms. Studies have shown that neck pain is more common in individuals with migraine than in the general population, and research suggests this rate may be approximately 10-12 times higher compared to healthy individuals. Furthermore, it has been reported that individuals with migraine more frequently experience tenderness in cranio-cervical muscles such as the upper trapezius, sternocleidomastoid, and suboccipital muscles, myofascial trigger points, and increased muscle sensitivity. The literature also emphasizes that these cervical symptoms may be related to migraine frequency, attack severity, and headache-related disability. These findings suggest that migraine should be considered not only as a primary headache disorder but also as a complex neurobiological condition associated with widespread pain sensitivity and musculoskeletal symptoms. A better understanding of the relationship between migraine and musculoskeletal pain could be important for developing multidisciplinary treatment approaches. However, clinical studies in the literature that evaluate migraine, accompanying neck pain, and lower back pain together in terms of common pain mechanisms are quite limited. Therefore, the rationale for this study is that examining factors such as central sensitization, pain threshold, pain catastrophizing, psychological factors, body awareness, and regional disability together in migraine patients can lead to a better understanding of the pathophysiology of migraine-related musculoskeletal pain. Based on all these reasons and evidence, the aim of this study is to investigate the possible common pain mechanisms and musculoskeletal pathophysiological processes of migraine-related neck and back pain in migraine patients with accompanying neck and/or back pain by evaluating factors such as central sensitization, pain threshold, pain catastrophizing, psychological factors, body awareness, and regional disability together.

A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine

The purpose of this Phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine.

New Methods for Evaluating Preventive Migraine Treatment

The study aims to test interactions between drug and placebo-responses in acute migraine treatment and to assess variation in adverse events according to treatment information provided. Using a clinical within-subjects, balanced placebo design, patients with chronic migraine will receive four treatment conditions in a randomized order.

Central Sensitization, Work-Related Stress, and Musculoskeletal Symptoms in Desk-Based Workers With and Without Migraine

Migraine is a common neurological disease causing significant disability worldwide, with an estimated global prevalence of 14.4%. It represents a significant individual and societal burden, particularly for working-age individuals, as it can significantly impact work performance, productivity, and daily living activities. Migraine is not merely a headache; it is characterized by increased excitability of neurons in the central nervous system, leading to hypersensitivity to pain. Central sensory mechanisms are thought to play a role in the pathophysiology and chronicity of migraine, causing increased pain sensitivity, allodynia, and potentially related to musculoskeletal pain. Furthermore, psychosocial factors and work stress have been identified as significant factors associated with both headaches and musculoskeletal pain. Literature indicates that neck pain is common in individuals with migraine headaches; in fact, neck pain is twice as frequent in patients with chronic migraine headaches compared to those with episodic migraine. While evidence regarding back pain is limited, it has been shown that individuals with chronic headaches report back pain more frequently. In modern work environments, sedentary work and prolonged computer use are increasing. Prolonged sitting, improper ergonomics, and repetitive movements are considered significant risk factors for musculoskeletal problems. This can lead to pain and functional limitations, particularly in the neck, shoulders, and back. Although there has been an increase in working from home, especially after the pandemic, the time spent at a desk is still similar to that spent in the workplace. It is stated that static muscle activity and improper postures maintained during prolonged computer use can lead to increased strain on cervical and upper extremity muscles, exacerbating musculoskeletal symptoms. Literature reports that headaches and neck pain are common among individuals who work at desks; for example, a study of office workers reported that approximately 80% of individuals with headaches also experienced neck pain. Furthermore, high workload, time pressure, and psychosocial stress factors have been shown to be associated with both headaches and musculoskeletal pain in individuals who work at desks. Therefore, desk-based work conditions are considered a significant environmental factor that may play a role in the onset or exacerbation of migraine and musculoskeletal symptoms. Despite this, studies examining musculoskeletal symptoms, central sensitivity, and work stress together in desk-bound migraine patients are limited in the literature. Most studies have only examined individuals with headaches or evaluated musculoskeletal findings in limited areas. Therefore, studies comparing desk-bound migraine patients with non-migraine-bound desk-bound individuals could fill a significant gap in the literature. In this context, it is believed that the planned study will contribute to a better understanding of the possible relationships between migraine and musculoskeletal symptoms, help develop protective and rehabilitative approaches to the work environment, and benefit individuals exposed to musculoskeletal risks in desk-bound work, within the scope of Sustainable Development Goals 3: ensure healthy lives and promote well-being for all at all ages. The aim of this study is to compare central sensitization, work-related stress levels, and musculoskeletal symptoms in desk-based workers according to the presence of migraine and to examine the relationships among these variables.

Effects of Progressive Muscle Relaxation Training Applied in Addition to Aerobic Exercise Training in Individuals With Migraine Diagnosis

Aim: The purpose of this study is to evaluate the effects of progressive muscle relaxation training, in addition to aerobic exercise training, on pain, disability, quality of life, psychological status, and functional capacity in individuals diagnosed with migraine. Methods: The study population comprises migraine patients who presented to the Neurology Clinic of Mardin Training and Research Hospital. Participants meeting the inclusion criteria will be randomized into two groups: an exercise group and a control group. The exercise group will receive both aerobic exercise and progressive muscle relaxation training, while the control group will receive only aerobic exercise. Participants' physical and demographic characteristics, as well as migraine-associated symptoms, will be assessed and recorded. Pain characteristics will be evaluated using a pain diary and pressure pain threshold measurements of the head and neck muscles. Disability will be assessed with the Migraine Disability Assessment Scale (MIDAS). Quality of life will be measured using the Headache Impact Test (HIT-6). Psychological status will be evaluated with the Hospital Anxiety and Depression Scale (HADS). Functional capacity will be assessed clinically using the 6-Minute Walk Test.

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)

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, at least 2 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.

Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed. Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 496 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico. Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and 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.

A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications

The main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (CGRP).

Impact of GON PRF on Central Sensitization in Migraine Patients

Background: Central sensitization and cutaneous allodynia are key mechanisms implicated in migraine chronification and disability. Pulsed radiofrequency (PRF) of the greater occipital nerve (GON) has emerged as a neuromodulatory intervention for refractory headache disorders; however, its effects on central sensitization remain insufficiently characterized. Objective: To prospectively evaluate changes in central sensitization, allodynia, and migraine-related disability following GON pulsed radiofrequency in patients with migraine. Methods: In this prospective observational study, adult patients with episodic or chronic migraine undergoing ultrasound-guided GON pulsed radiofrequency were evaluated at baseline and at 1 and 3 months post-procedure. Central sensitization was assessed using the Central Sensitization Inventory (CSI), cutaneous allodynia using the Allodynia Symptom Checklist (ASC-12), and migraine-related disability using the Migraine Disability Assessment Scale (MIDAS). Monthly headache days and acute medication use were also recorded. Results: Changes in CSI, ASC-12, MIDAS scores, headache frequency, and acute medication use over follow-up were analyzed using repeated-measures statistical methods. Conclusions: This study provides prospective data on sensory and clinical outcomes following GON pulsed radiofrequency, contributing to the understanding of its potential role in modulating central sensitization in migraine.

MMA Embolization for Refractory Chronic Migraine

This is a prospective, multi-center, feasibility study to investigate safety and effectiveness of TRUFILL n-BCA liquid embolic system in bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine.

A Dual Intervention in Migraine Treatment: Tens and Exercise

The aim of this clinical trial was to investigate the effects of TENS and exercise training on pain and disability in women diagnosed with migraine. The second aim was to investigate the effects of TENS and exercise training on muscle strength, flexibility, sleep quality, balance, and quality of life in women diagnosed with migraine. Study hypotheses: H1: TENS and exercise training are effective on pain in women with migraine. H2: TENS and exercise training are effective on disability in women with migraine. H3: TENS and exercise training are effective on muscle performance in women with migraine. H4: TENS and exercise training are effective on flexibility in women with migraine. H5: TENS and exercise training are effective on sleep quality in women with migraine. H6: TENS and exercise training are effective on balance in women with migraine. H7: TENS and exercise training are effective on quality of life in women with migraine.

Consistency of Response With Rimegepant in Acute Treatment of Migraine

This is a non-interventional, prospective study that will enroll participants with migraine in the United Kingdom currently in use of rimegepant to acutely treat migraine attacks. Participants will be followed up for up to 12 weeks and will complete a daily questionnaire to self-report the consistency of response to rimegepant in acute treatment of migraine.

A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

The goal of this clinical trial is to learn whether a home-based virtual reality (VR) neurofeedback program is feasible and acceptable for adolescents with migraine. The study will also explore whether the program may improve headache-related outcomes. The main questions it aims to answer are: Is it feasible to enroll, randomize, and retain adolescents with migraine in this study? Do participants complete the VR sessions and study procedures as intended? Are there preliminary signals that the VR neurofeedback program may improve headache-related disability and symptoms? Researchers will compare Immersive Neurofeedback Self-Regulation Training (INSeRT), which uses brain activity recorded from a wearable electroencephalogram (EEG) headband to guide the VR experience, to a comparison VR program that presents immersive imagery without neurofeedback or guided relaxation training. Participants will: Complete a 4-week baseline period that includes headache logs, questionnaires, and a laboratory EEG assessment Be randomly assigned to one of two VR programs Complete VR sessions at home three times per week for 4 weeks Complete questionnaires at the end of treatment and again approximately 3 months later Repeat the laboratory EEG assessment at the end of treatment