Aliso Viejo

Researchers are evaluating the effectiveness and safety of CREXONT, a combination of Carbidopa and Levodopa in extended-release capsules, in people with Parkinson's disease (PD) under real-world conditions. This Phase 4 study focuses on participants who have PD diagnosed according to specific criteria and experience motor fluctuations and "Off" periods despite stable treatment with oral Carbidopa-Levodopa. Participants will receive CREXONT ER capsules during the study. The study includes a treatment period lasting 42 days, during which participants continue their PD medication regimen while taking CREXONT. The study assesses changes in the amount of time participants spend in the "Good On" state, where motor symptoms are well controlled. Throughout the study, participants will complete Parkinson's Disease diaries, questionnaires, and attend study visits and phone calls. Researchers will monitor motor function using standardized rating scales and diary entries to evaluate changes in motor states from the start of the study to Day 42. Safety and adherence to treatment will also be assessed during this period.

Researchers are studying individuals aged 12 to 65 who have isolated (or primary) dystonia affecting more than one area of the body. This observational study aims to collect detailed information about how dystonia impacts daily life, including aspects such as well-being, pain, relationships, and social interactions. The study also seeks to understand how the disease changes over time and to evaluate commonly used clinical scales for measuring dystonia symptoms. The information gathered will help support future clinical research in this patient population. No treatments are given as part of this study since it is observational. Participants will undergo assessments using various clinical rating scales to measure the severity and impact of their dystonia. Researchers will also gather detailed medication histories and note any health events like hospitalizations or new diagnoses during the study period. Participants will be asked to complete assessments over time to track changes in their condition. These include evaluations based on the Burke-Fahn-Marsden Dystonia Rating Scale. The study will monitor disease progression and impact without intervening in the participant's usual care. This process helps researchers better understand the condition and the reliability of clinical scales used for dystonia. The total participation duration depends on the study schedule but involves multiple visits for data collection and observation.

Migraine is a neurological condition causing moderate to severe headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. This research aims to assess how well atogepant works in adults with migraine when used in everyday medical practice. Atogepant is an approved preventive treatment for migraines, and the study will include about 1000 adult participants prescribed this medication by their doctors worldwide. Participants will take atogepant tablets orally as prescribed by their healthcare providers following usual medical care. The study will observe participants over a two-year period without requiring extra treatments or procedures beyond their regular clinical visits. These visits will occur at hospitals or clinics according to each participant's routine care schedule. During the study, participants will attend regular check-ups where researchers will monitor their health and migraine symptoms. The main outcome measured will be the percentage of participants who report feeling "much better" or "very much better" by week 12, based on their own impression of change. There are no additional burdens expected for participants beyond their normal treatment and follow-up appointments.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

This research aims to understand real-world patient experiences using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in people with Parkinson's Disease in the United States. It is a prospective, Phase 4, multicenter observational study designed to gather information on how patients use ONAPGOTM and their outcomes while receiving this treatment under usual care conditions. Participants first go through an Enrollment Day, which can occur anytime between their ONAPGOTM prescription and starting the infusion. Before beginning ONAPGOTM, there is a Baseline Period that includes in-home education by a specially trained Clinical Nurse Navigator (CNN) on how to use ONAPGOTM. The study then follows participants through Dose Initiation, Titration, and Optimization phases according to their prescription, followed by a Maintenance Period with standard care visits from the CNN. The study concludes with an End-of-Study or Discontinuation Visit. During the study, researchers monitor how long it takes participants to reach their optimized dose, how many dose adjustments or visits are needed, and any changes in other Parkinson's medications over approximately 52 to 60 weeks. The study involves regular assessments and support from the CNN to help participants manage their treatment and measure their response and safety throughout the entire period.

This research aims to collect data on the worldwide use and outcomes of Boston Scientific's Vercise Deep Brain Stimulation (DBS) System in treating Parkinson's disease. The study also evaluates the use of Image Guided Programming (IGP) and the DBS Illumina 3D feature as tools to assist in programming the DBS device for patients. Participants receiving DBS for Parkinson's symptoms will be included in this registry. The study observes how these programming features are applied in clinical settings to optimize treatment. There are no additional treatment groups or drug comparisons as this is a device registry. During the study, participants' symptom improvements and overall quality of life will be monitored and compared to their condition before DBS. The study follows patients for up to three years to assess long-term benefits and outcomes. Data collection includes evaluations of symptom changes and the effectiveness of programming tools used with the DBS system.

Migraine is a neurological condition that involves moderate to severe headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. This research evaluates how oral ubrogepant affects the severity of migraine attacks in adult patients when used during the early warning phase called the prodrome. About 189 adults diagnosed with migraine will participate across approximately 15 sites in the United States. Participants will continue using ubrogepant as prescribed by their physician according to routine clinical practice and the approved labeling. The study does not involve additional treatments or experimental interventions beyond their usual care. Participants will be followed for up to 13 weeks to observe changes in migraine attack severity and treatment effectiveness. During the study, participants will attend regular visits at hospitals or clinics as part of their routine care, with no extra burden expected. Researchers will measure how many participants experience no moderate to severe headache within 24 hours after dosing during the prodrome phase. The study focuses on collecting real-world data about ubrogepant's acute use in migraine treatment over this period.

Researchers are evaluating TB006, a monoclonal antibody targeting Galectin-3, in adults aged 18 to 35 with moderate or higher severity Autism Spectrum Disorder (ASD). This phase 2, multi-center, double-blind, placebo-controlled clinical trial aims to assess whether TB006 can improve core and associated behavioral symptoms of ASD by reducing neuroinflammation linked to immune dysregulation. The study is designed to measure safety and efficacy, focusing on the role of Galectin-3 in activating microglia and contributing to ASD symptoms. Eligible participants are randomized in a 2:1 ratio to receive either TB006 or a placebo over a 14-week double-blind treatment period. After this phase, those who initially received placebo may enter a 14-week open-label extension to receive TB006. TB006 is a humanized immunoglobulin G4 monoclonal antibody specifically targeting human Galectin-3. Participants continue their current complementary, dietary, traditional, and behavioral treatments unchanged throughout the study to isolate the effect of TB006. Participants will be assessed at baseline, week 8, and week 14 using the Childhood Autism Rating Scores (CARS) to track changes in autism symptoms. Caregivers will assist with questionnaires, and safety monitoring includes laboratory tests and evaluation of vital signs. The study ensures careful screening and monitoring to maintain participant safety and data integrity over the entire 14- to 28-week participation period, including the open-label extension.