Apopka

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 years who have mild to severe Alzheimers Disease AD with moderate to severe psychosis related to AD. This Phase 3 study aims to compare KarXT with a placebo to see how well it works in treating psychosis symptoms associated with AD, focusing on changes in hallucinations and delusions. Participants will receive either KarXT capsules at varying doses or placebo capsules in a randomized, double-blind setup. The treatment period lasts up to 14 weeks, during which participants take the assigned capsules daily. The study design includes two groups running in parallel, with neither participants nor researchers knowing who receives the drug or placebo. During the study, participants will undergo assessments including the Neuropsychiatric Inventory-Clinician NPI-C focusing on hallucinations and delusions, Clinical Global Impressions-Severity scale, and other related scales to measure psychosis symptoms and caregiver distress. Safety and efficacy will be monitored throughout, with evaluations at baseline and at the end of treatment. The entire participation period extends up to 14 weeks.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the safety and effectiveness of BHV-3000 rimegepant compared to a placebo for treating moderate to severe migraine attacks in children and adolescents aged 6 to under 18 years. This Phase 3 clinical trial focuses on acute migraine treatment in a pediatric population, aiming to measure pain freedom two hours after dosing and other migraine-related symptoms to understand how well the treatment works in this age group. Participants receive either BHV-3000 rimegepant 75 mg or 50 mg orally disintegrating tablet ODT, or a matching placebo tablet. The study uses a randomized, double-blind design where participants are assigned to one of these groups. The trial monitors the effects of the medication shortly after administration and compares outcomes between the active drug and placebo groups. During the study, participants will be assessed for pain relief, freedom from the most bothersome migraine symptoms, and need for rescue medication within 24 to 48 hours after treatment. Researchers will also evaluate sustained pain freedom and the ability to function normally following the migraine attack. Various outcome measures include pain and symptom assessments at 2 hours post-dose, along with tracking medication use and migraine impact. The trial lasts until the primary completion date in January 2029, with ongoing safety and efficacy monitoring throughout.