Migraine Clinical Trials in Cincinnati, OH

The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing chronic migraine. A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Chronic migraine is defined as having at least 15 days of headache a month with at least 8 of those days being migraine headache days. Migraines are caused by a series of events which cause the brain to get stimulated/activated, which results in the release of chemicals that cause pain. Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers. The study will consist of 3 periods: 1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit. 2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders. The injections will contain either a dose "A" or dose "B" of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied). Participants will make 4 visits to the clinic in person and have 4 remote (online) visits. 3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36, all participants will get Dysport® (dose "A" or dose "B"). There will be 3 in person visits and 4 remote visits. Participants will need to complete an e-diary and questionnaires throughout the study. Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded. The total study duration for a participant will be up to 60 weeks (approx. 14 months). Read Less

The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period. Read Less

A migraine is a moderate to severe headache 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. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires. Read Less

The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability. Read Less

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are: * Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain? * What are predictors of recovery from chronic pain? * What brain systems are associated with the spread of pain? For this study participants will undergo: * Functional Magnetic Resonance Imaging (fMRI) * Quantitative Sensory Testing * Psychological Assessments Read Less

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. Read Less

The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine. Read Less

A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age. Read Less

This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction. Read Less

The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1. If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls. 2. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth. Participation includes: * quantitative sensory testing * blood draw * sleep assessment * questionnaires Read Less