Petersburg

Researchers are evaluating real-world treatment patterns, effectiveness, and side effects of xanomeline and trospium chloride (KarXT) in adults diagnosed with schizophrenia in the United States. This study aims to describe how patients respond to KarXT treatment and the related adverse events as observed in routine clinical care. Participants receive xanomeline and trospium chloride (KarXT) following the product label instructions. They may either be starting KarXT treatment within 16 weeks with plans to stop previous antipsychotics or already on a stable antipsychotic regimen and switching to KarXT under their clinician's guidance. Other psychiatric medications like antidepressants or mood stabilizers can be continued at stable doses during the study. During the study, participants' treatment adjustments and switches are tracked from baseline up to 20 weeks. Researchers monitor treatment effectiveness and safety through regular clinical follow-up, recording any changes, side effects, or adverse events. The study relies on the treating clinician’s judgment to assess treatment progress and participant safety throughout the observation period.

Researchers are evaluating the efficacy and safety of SPN-812 (viloxazine extended release) in children aged 4 to 5 years who have Attention-Deficit/Hyperactivity Disorder (ADHD). This Phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to compare SPN-812 with a placebo in this preschool-age population to better understand its effects on ADHD symptoms. Participants will be randomly assigned to receive either 100 mg of SPN-812 or a placebo once daily for 6 weeks. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. The total study duration is up to 10 weeks, including screening and treatment phases. The study uses a fixed dose and parallel-group design, meaning participants receive one treatment throughout the study. During the study, children will be assessed for changes in ADHD symptoms using a specific rating scale from the start of treatment through Week 6. Researchers will monitor safety and tolerability throughout the trial. Parents or guardians will provide consent and participate in assessments to track symptom changes and treatment effects. The study includes regular evaluations to measure ADHD symptom severity and overall clinical impression.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of lumateperone in treating irritability associated with Autism Spectrum Disorder (ASD) in children and adolescents aged 5 to 17 years. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants diagnosed with ASD and confirmed irritability symptoms using standard diagnostic tools. The study consists of three phases: a screening period lasting up to 14 days to check eligibility, a 6-week double-blind treatment period where participants will be randomly assigned to receive either a high dose of lumateperone, a low dose of lumateperone, or a placebo once daily, and a 1-week safety follow-up period after the last dose to monitor participants' well-being. During the study, participants will be monitored for changes in irritability using the Aberrant Behavior Checklist - Irritability subscale at week 6. Safety evaluations will occur during the follow-up visit approximately one week post-treatment. Throughout the trial, assessments will include clinical evaluations and caregiver reports to track symptoms and any side effects, ensuring participant safety over the approximately seven-week participation period.

Researchers are evaluating a new medicine called PF-08634404 to see how well it works in adults with colorectal cancer that has spread or returned after previous treatments. This study focuses on whether PF-08634404 combined with approved chemotherapy can help patients compared to another approved medicine called Bevacizumab combined with chemotherapy. The study is a Phase 3, double-blind, randomized trial involving participants who have metastatic colorectal cancer and have not received prior systemic therapy for metastatic disease. Participants will be randomly assigned to one of two groups: one receiving PF-08634404 plus chemotherapy, and the other receiving Bevacizumab plus chemotherapy. Both treatments are given by intravenous infusion in cycles. Participants may continue treatment if it is beneficial and side effects are manageable. Treatments are administered at clinical sites with medical staff monitoring participants during and after each infusion. During the approximately 33-month study, participants will visit the study site regularly for treatment, health checks, and tests. After stopping treatment, there will be a follow-up visit about 30 to 37 days later to assess health and side effects. Participants will also have follow-up every 12 weeks by phone, in person, or through health record reviews to monitor their health status and any new treatments. The main outcomes measured include progression-free survival and overall survival over about 4 years.