Apopka

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of KarXT in men and women aged 55 to 90 years who have mild to severe Alzheimer's Disease with moderate to severe psychosis related to the condition. The main goal is to compare KarXT against a placebo by measuring changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician (NPI-C) score. Participants will receive different doses of KarXT ranging from 20/2 mg to 66.7/6.67 mg daily or placebo capsules. The study is designed to compare the effects of KarXT with placebo in a parallel group format, maintaining the double-blind setup to ensure unbiased results. During the study, participants will be assessed at the start and end of treatment (up to 14 weeks) to evaluate changes in psychotic symptoms. They will undergo clinical scales such as the NPI-C and the Clinical Global Impression-Severity (CGI-S) scale. The study also requires imaging scans like MRI or CT to rule out other brain diseases. A study partner who has regular contact with the participant will be involved to support adherence and observation. Safety and efficacy will be monitored throughout the treatment period.

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.

This research aims to test 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. The study focuses on pediatric migraine, including attacks with or without aura, lasting more than 3 hours and occurring 1 to 8 times per month over the previous two months. Participants must be able to clearly distinguish migraine from other headaches and weigh more than 40 kg. Participants will receive either BHV-3000 (rimegepant) at doses of 75 mg or 50 mg as an orally disintegrating tablet (ODT) or a matching placebo. The study is randomized, double-blind, and placebo-controlled, designed to evaluate the acute treatment effect. Some participants may continue stable migraine preventive medications, but use of CGRP antagonist drugs is not allowed. The treatment phase will monitor responses to the study drug during migraine attacks. During the study, participants will be assessed for migraine pain relief two hours after dosing, measuring how many experience complete freedom from pain. Blood samples will be taken, and participants will be monitored for safety and side effects. The study excludes those with certain headache types, significant psychiatric or neurological conditions, recent surgeries, or other serious medical issues that could affect participation or safety. Overall, the study evaluates both the effectiveness and safety of rimegepant in a pediatric population over the course of migraine attacks.