Aliso Viejo

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo vehicle in adults with Dry Eye Disease DED who have a specific TNFR1 genotype. This study is a phase 2b3, double-masked, randomized, vehicle-controlled trial aimed at understanding how licaminlimab affects symptoms of dry eye in this particular group. Participants first undergo a run-in period using artificial tear drops three times daily for about 14 days. Following this, they are randomly assigned to receive either licaminlimab eye drops or a placebo vehicle, both administered three times daily for 29 days. The study compares these two treatments to assess their impact on dry eye discomfort. During the study, participants eye discomfort severity is measured at the start and after 29 days of treatment, focusing especially on those with the specific genotype. Additional assessments include overall symptom changes regardless of genotype. The study tracks safety and effectiveness over this period, with the total participation lasting approximately 43 days including the run-in and treatment phases.

Researchers are evaluating the effectiveness and safety of CREXONT, an extended-release capsule containing Carbidopa and Levodopa, in people with Parkinson disease PD under real-world conditions. This Phase 4 study aims to understand how well CREXONT works in reducing motor symptom fluctuations in participants who are already treated with stable oral Carbidopa-Levodopa regimens. Participants will receive CREXONT extended-release capsules orally, with doses guided by FDA-approved prescribing information. The capsules come in several strengths, and dosing will be adjusted individually to find the best balance between effectiveness and tolerability. The study includes an initial dosing based on prior oral medication and allows optimization throughout the study to meet each participants needs. During the study, participants will complete Parkinsons Disease diaries to track On and Off motor states, and researchers will measure changes in Good On time and Off time by Day 42 compared to baseline. Participants will attend study visits and may receive questionnaires and assessments to monitor their condition and treatment response. The study is open-label, meaning all participants receive CREXONT, and the total participation duration includes baseline and follow-up assessments through Day 42.

Researchers are conducting an observational study focused on individuals diagnosed with isolated or primary dystonia affecting more than one body region. The study aims to collect detailed information to better understand how dystonia affects patients lives and how the disease changes over time. It also seeks to evaluate common clinical scales used to assess dystonia symptoms and their impact on well-being, pain, relationships, and social interactions. This study enrolls up to 200 male and female participants aged 12 to 65 years who have had isolated dystonia for at least one year. Participants must have segmental, multifocal, or generalized dystonia but not focal dystonia limited to a single body part. No interventional treatments are given, as this is a noninterventional, prospective observational study. Participants will undergo assessments using standardized rating scales, including the Burke-Fahn-Marsden Dystonia Rating Scale and other clinical measures, over a period of 4 months. Researchers will also collect medication history and monitor health events such as hospitalizations or new diagnoses. The data gathered will support future interventional studies and improve understanding of dystonia and clinical rating scales.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

This observational study focuses on people with Parkinsons Disease who are prescribed continuous subcutaneous apomorphine infusion ONAPGO. It aims to collect real-world patient experiences using this infusion in the United States, evaluating how patients manage their treatment and adjust medications over time. The study is a Phase 4, multicenter trial sponsored by Supernus Pharmaceuticals, Inc., designed to better understand patient and caregiver experiences with this therapy. Participants go through several study periods Enrollment Day occurs anytime between their prescription for ONAPGO and starting the infusion a Baseline Period includes in-home education by a Clinical Nurse Navigator followed by Dose Initiation, Titration, and Optimization phases according to prescription. After dose optimization, participants enter a Maintenance Period with ongoing standard care visits by the Clinical Nurse Navigator, ending with a final study or discontinuation visit. Throughout the study, participants are monitored for how long it takes to reach an optimized dose, adjustments to Parkinsons medications, and the number of dose changes needed over approximately 52 to 60 weeks. Researchers also assess patient global health improvement, caregiver burden, healthcare provider burden, infusion usage during maintenance, and safety by tracking adverse events. Participants will have regular interactions with healthcare providers and complete various assessments over the study duration.

This research aims to gather global outcome data on the use of Boston Scientifics Vercise Deep Brain Stimulation DBS System for treating Parkinsons disease. It evaluates how well the device improves symptoms and overall quality of life for patients. The study also assesses the use of Image Guided Programming IGP and the DBS Illumina 3D feature as tools for programming the DBS system. Participants receive DBS therapy using the Vercise system, which is commercially available and intended to manage Parkinsons disease symptoms. The study monitors how these programming tools assist in customizing treatment for individual patients. Participants included are those undergoing this therapy as part of their clinical care. During the study, researchers assess changes in disease symptoms and quality of life compared to baseline before DBS treatment. These assessments continue for up to three years. The study collects data on the use of programming features and tracks participants progress and well-being throughout the follow-up period. Safety and cognitive or psychiatric status are also monitored as part of the evaluation.

Migraine is a neurological condition marked by moderate to severe headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. This research evaluates changes in migraine attack severity among adults using oral ubrogepant during migraine attacks. The study will include about 189 adult participants across approximately 15 sites in the US. Participants will take ubrogepant as prescribed by their physicians according to routine clinical practice and local approved guidelines. This observational study involves no experimental treatment changes and follows participants for up to 13 weeks. During this time, participants receive their usual migraine care without additional intervention. Participants will attend regular visits at hospitals or clinics as part of their routine care during the study period. Researchers will monitor the percentage of participants experiencing absence of moderate to severe headache over 24 hours after dosing during the prodrome phase of migraine attacks. The study aims to track real-world effectiveness without adding extra burden to participants.

Researchers are evaluating TB006, a monoclonal antibody targeting Galectin-3, in adults with Autism Spectrum Disorder ASD. This study explores whether TB006 can improve core and associated behavioral symptoms by reducing neuroinflammation linked to increased microglial activation. The trial is a Phase 2, multisite, double-blind, placebo-controlled randomized clinical trial with a 14-week treatment phase followed by a 14-week open-label extension for placebo subjects. Participants will be randomly assigned in a 21 ratio to receive either TB006 or a placebo. TB006 is given as an intravenous infusion and is designed to neutralize Galectin-3, which is elevated in individuals with ASD. Those initially receiving placebo will have the opportunity to receive TB006 during the open-label extension. The study measures changes in autism symptoms using various clinical scales over the 14 weeks. During the study, participants will attend regular visits for assessments including Childhood Autism Rating Scores CARS at baseline, week 8, and week 14. Additional evaluations include the NIH Toolbox, Clinical Global Impression Scale, Social Responsiveness Scale, and behavioral checklists. Caregivers will also provide input through questionnaires. Safety monitoring includes vital signs and laboratory tests. Overall participation spans the double-blind phase and potential open-label extension, totaling up to 28 weeks.