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A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents with Chronic Migraine
Rochester, MN
To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
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Assessment of LBR-101 In Chronic Migraine
Scottsdale/Phoenix, AZ
The purpose of the study is to determine whether monthly subcutaneous administration of LBR-101 is safe and provides migraine prevention in patients with chronic migraine.
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OnabotulinumtoxinA as a Treatment for Hemiplegic Migraine
Rochester, MN
Hemiplegic migraine is a rare subtype of migraine with aura, with symptoms affecting vision, speech and language, hearing, and sensory and motor disturbances. Muscle weakness and hemiplegia are defining characteristics of hemiplegic migraines. Compared to patients with typical migraine with aura, patients with hemiplegic migraine tend to have more prolonged aura symptoms. In some cases, reversible unilateral weakness may last days to weeks. The primary objective of this project is to evaluate the response of hemiplegic migraine patients evaluated at Mayo Clinic to onabotulinumtoxinA treatments.
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The MOTS (Medication Overuse Treatment Strategy) Trial
Scottsdale/Phoenix, AZ; Rochester, MN
There are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. This study will compare the outcomes amongst patients randomized to one of the two treatment strategies.
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Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE
Scottsdale/Phoenix, AZ
The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.
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A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine
Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether monthly subcutaneous administration of LBR-101 is safe and provides migraine prevention in subjects with high frequency episodic migraine.
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Metformin for the Prevention of Episodic Migraine (MPEM)
Scottsdale/Phoenix, AZ
Migraine is the third most prevalent disease in the world. Preventive treatment is indicated in about 40% of individuals with episodic migraine. Although 4 treatments are approved by the US Food and Drug Administration for prevention of episodic migraine, none were designed to prevent migraine, efficacy is modest, and all have significant adverse-event profiles. As a result, less than 1/3 of migraine sufferers with who are candidates for prevention receive drug treatment and of those who are treated, more than 85% have discontinued the preventive drug within one year. Migraine pain is associated with the activation and sensitization of specific ...
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A Study of the Individualized Prediction of Migraine Attacks Using a Mobile Phone App and Fitbit Data
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the accuracy of predicting migraine attacks in individual patients using a mobile phone app and a Fitbit to collect daily headache diary data, exposure/trigger data and physiologic data. It is believed the data will predict the occurrence of migraine attacks with high accuracy via the mobile phone app.
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A Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
Scottsdale/Phoenix, AZ
The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.
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A Study to Evaluate Neuroimaging of Men with Migraine
Scottsdale/Phoenix, AZ
The purpose of this study is to find sex-based differences in migraine-related functional connectivity. To achieve this, men with migraine will be compared to men healthy controls and women with migraine will be compared to women healthy controls.
Men and women with migraine will then be compared, using region-pairs that differed in the single-sex comparisons. Identification of migraine-related, sex-specific, functional imaging aberrations will provide insights into sex-specific migraine pathophysiology and will inform future imaging studies
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A Study of Speech Changes as Predictors of Migraine Attack Onset
Scottsdale/Phoenix, AZ
The purpose of this study is to predict migraine headache onset from changes in speech in people who have a history of migraines.
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A Study of Migraine Attack Prediction for Improved Patient Outcomes
Scottsdale/Phoenix, AZ
The purpose of this study is to create individualized prediction models utilizing sensor data and cognitive function which will accurately identify the premonitory phase of the migraine attack and predict an oncoming migraine headache.
This study will seek to determine which measures differ between migraine attack phases (e.g., interictal vs. premonitory), develop an initial migraine prediction algorithm, and to provide insights into how long prior to headache onset premonitory changes begin. It will also look for migraine phenotypes associated with changes in sensor-measured data during the preictal vs. ictal or interictal periods.
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Rizatriptan for Episodic Dizziness in Vestibular Migraine
Rochester, MN
The purpose of this study is to look at the natural history of VM and learn more about common symptoms. Investigators also want to learn the effects, both positive and negative, of the commonly used migraine drug, rizatriptan, when it is used for spells of dizziness in people with VM.
Patients may be eligible to participate if:
- Patients are between the ages of 18 & 65
- Patients have a history of vestibular migraine
- Patients are able to maintain a vestibular symptom diary
The study includes 3 visits with compensation. All participants must ...
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Transnasal Cooling for Migraine
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.
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A Study to Evaluate the Safety of Fremanezumab in Patients with Migraine in Routine Clinical Practice
Rochester, MN
The purpose of this study is to evaluate the long-term safety of Fremanezumab in all patients with migraine through evaluation of incidence of all adverse events.
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MRI Study To Identify Functional and Structural Changes That Correlate with Patient Improvement When Imaging the Brain Pre-and-Post Erenumab
Scottsdale/Phoenix, AZ
The purpose of this study is to identify changes in brain function and structure that correlate with response to erenumab, and to develop models using imaging data to predict which patients will respond to erenumab.
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Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
Scottsdale/Phoenix, AZ
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.
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A Multicenter Assessment of ALD403 in Chronic Migraine
Scottsdale/Phoenix, AZ
The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.
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Digital Biomarkers for Objectively and Remotely Monitoring Migraine
Scottsdale/Phoenix, AZ
Changes in vision are commonly reported by patients during migraine attacks. Even in patients that do not report changes in vision, we have noted objective changes as demonstrated by changes in the King-Devick Test (KDT), a quantitative measure of rapid eye movement; which was 6.5 seconds slower (SD 7.6 seconds, p<0.001) during a migraine attack compared to between migraine attacks. this study aims to evaluate changes in timed rapid number naming using the kdt during the twelve hours prior to a migraine attack (“pre-attack” phase) and during the migraine attack compared to the between attack phase. accurate prediction of an ... during="" a="" migraine="" attack="" compared="" to="" between="" migraine="" attacks.="" this="" study="" aims="" to="" evaluate="" changes="" in="" timed="" rapid="" number="" naming="" using="" the="" kdt="" during="" the="" twelve="" hours="" prior="" to="" a="" migraine="" attack="" (“pre-attack”="" phase)="" and="" during="" the="" migraine="" attack="" compared="" to="" the="" between="" attack="" phase.="" accurate="" prediction="" of="" an="" ...="">0.001) during a migraine attack compared to between migraine attacks. this study aims to evaluate changes in timed rapid number naming using the kdt during the twelve hours prior to a migraine attack (“pre-attack” phase) and during the migraine attack compared to the between attack phase. accurate prediction of an ... >
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A Study of King-Devick test (KDT) and Visual Contrast Sensitivity (VCS) Test Can Detect Migraine Attacks
Scottsdale/Phoenix, AZ
This research study is being done to help determine if King-Devick test (KDT) and Visual Contrast Sensitivity (VCS) can detect migraine-induced cerebral function changes.
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Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness
Scottsdale/Phoenix, AZ; Rochester, MN
Chronic dizziness and recurrent vertigo are frequent complaints in primary and specialty medical care settings. Two common causes of these symptoms are vestibular migraine (VM) and chronic subjective dizziness (CSD), which may be seen in up to 25% of patients examined in tertiary neurotology centers. However, VM and CSD are relatively new diagnoses that have not yet been validated. Furthermore, recent research found that they co-exist 30% of the time with overlap in several features. From a clinical standpoint, this makes it difficult to diagnose and treat them well. From a research standpoint, it confounds subject selection for mechanistic investigations.
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Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
Scottsdale/Phoenix, AZ
The study sponsor has developed a non-invasive treatment for reducing migraine pain. The Theranova Migraine Treatment System uses electrical stimulation applied to the skin.
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A Study to Evaluate Intravenous Erenumab in Patients with Status Migrainosus
Scottsdale/Phoenix, AZ
The purpose of this study is to investigate the use of erenumab 140mg IV in patients with status migrainosus. The specific aims of the study are to evaluate early endpoints of response including pain freedom at 2 hours, absence of the most bothersome symptom (MBS) at 2 hours, change in pain severity at 2 hours, and sustained pain freedom at 24 hours, and to evaluate late endpoints of response including change in migraine days at 4 weeks compared to baseline report, change in headache days at 4 weeks compared to baseline report, and change in acute medication use.
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Wearable Devices to Predict and Track Chronic Migraine Clinical Outcomes
Rochester, MN
The purpose of this study is to accurately track biomarkers of headache coupled with patient reporting of severity with minimal effort by the patient using a custom phone app integrating patient and devices. Also, to accurately forecast periods of increased headache likelihood to allow patients earlier and more effective treatments.
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A Study of Structural and Functional Brain Characteristics in Patients with Headache Disorders Using Neuroimaging
Scottsdale/Phoenix, AZ
The purpose of this study is to use structural and functional neuroimaging to compare what regional brain changes are similar or distinctly different between migraines and TAC ( trigeminal autonomic cephalagias).
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An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
Scottsdale/Phoenix, AZ
This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.
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A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
Scottsdale/Phoenix, AZ
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
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A Prospective Validation Study of Early Prediction of Migraine Preventive Treatment Response
Scottsdale/Phoenix, AZ
The purpose of this study is to test the accuracy of a previously developed algorithm for predicting patient outcomes to migraine preventive treatments. Also, to optimize the performance of a previously developed algorithm for predicting patient outcomes to migraine preventive treatments.
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Prospective Comparison of Methods for Assessment for Headache Directionality
Scottsdale/Phoenix, AZ
The purpose of this study is to prospectively determine what method of assessment predicts headache directionality using three standardized methods: 1) pictorial representation, 2) standardized patient survey and 3) standardized headache neurology investigator assessment.
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A Study to Develop an MRI (Magnetic Resonance Imaging) Based System to Identify Persistent Posttraumatic Headaches as Different from Chronic Migraines
Scottsdale/Phoenix, AZ
The purpose of this study is to develop an MRI based model to accurately identify persistent posttraumatic headache related to mild traumatic brain injury, as different from chronic migraine.
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A Study to Evaluate Droperidol Use in the Emergency Department and the Effect on QTc
Rochester, MN
The purpose of this study is to study the length of the QTc interval in patients receiving the standard of care dose of intravenous droperidol for headache or migraine, nausea, pain, and indications other than agitation over 30 minutes.
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A Study of Prolactin Levels in Women with Chronic Migraine
Scottsdale/Phoenix, AZ
The purpose of this study is to identify whether there is a difference in prolactin levels between patients with chronic migraine and healthy controls. This may help to explain the sensitivity to pain those patients with chronic migraine experience and may also help to establish a target for new treatments of chronic migraine
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Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.
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Acute Procedural Pain Treated With Remote Electrical Neuromodulation in Chronic Migraine Patients Receiving Onabotulinumtoxina
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the effectiveness of remote electrical neuromodulation with Nerivio ® (Theranica Bio-electronics, Ltd.) for treatment of acute procedural pain in patients receiving onabotulinumtoxinA for the treatment of chronic migraine.
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A Study to Compare the Effectiveness of Using Tints or Thin-Films on Eye Glass Lens to Reduce Light Sensitivity for Patients with Chronic Migraine
Scottsdale/Phoenix, AZ
The purpose of this study is to compare eye glass lenses that have been treated with tints, to lenses that have been treated with thin-films to reduce light sensitivity and headache in patients who have chronic migraine. It is unknown if there is an advantage to either spectacle lens treatment. Both treatments could be a novel, non-invasive addition in the treatment of chronic migraine.
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Various Visual Symptoms in Children
Rochester, MN
The primary purpose of this study is determine the frequency of positive visual symptoms including visual snow in pediatric patients seen for general pediatric care as well as for neurologic care.
The secondary purpose is to determine if positive visual symptoms are more common in pediatric patients who also have a self-reported history of headache or migraine.
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White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology
Scottsdale/Phoenix, AZ
The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraine. We will accomplish this by comparing brain imaging and clinical assessments of women with migraine, small vessel ischemic (SVI) disease, and multiple sclerosis (MS).
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A Study to Evaluate the Safety and Effectiveness of GORE® CARDIOFORM Septal Occluder to Treat Migraine Headaches
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate Patent Foramen Ovale (PFO) closure for migraine headache relief using the GORE® CARDIOFORM Septal Occluder after a trial of oral anticoagulation therapy vs. placebo for a 6 week period.
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The Childhood and Adolescent Migraine Prevention Study
Rochester, MN
The purpose of this research study is to test two medicines for migraine prevention in children and adolescents. The investigators want to see if amitriptyline and/or topiramate are better than placebo (sugar pill) in reducing headache frequency in children and adolescents ages 8 to 17 with migraines. At this time, there are no FDA approved medicines approved in the US for the prevention treatment of migraine headaches in children and adolescents.
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A Study to Develop a Large-Scale Long-Term Database of Headache Disorders
Scottsdale/Phoenix, AZ
The purpose of this study is to enroll in a registry patients who have headache disorders, collecting detailed headache characteristics, biospecimens, and brain imaging data, to allow for more research into accurate diagnosis, prognosis, and treatments.
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Understanding Post-Traumatic Headache: Forward Translation of a Posttraumatic Headache Animal Model to Posttraumatic Headache in the Human
Scottsdale/Phoenix, AZ
Headache is the most commonly reported symptom after trauma to the head. Although posttraumatic headache (PTH) shares some clinical characteristics with primary headache disorders, such as migraine, there are many unique features including head trauma and the exacerbation of headache with physical and cognitive stressors. The purpose of this study is to determine if subjects who have recently sustained a mild TBI and have PTH will have lower pain thresholds (i.e. hyperalgesia) and greater allodynia compared to healthy controls. The study will also determine if exposure to a bright light stressor will exacerbate hyperalgesia in subjects with mild TBI and PTH ...