Orange Park

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.

Researchers are evaluating the long-term safety of rimegepant for treating acute migraine in children and adolescents aged 6 to under 18 years. This Phase 3, open-label study focuses on young individuals with a history of migraine with or without aura, aiming to understand the safety and tolerability of this treatment over time. Participants receive rimegepant orally in doses of 75 mg, 50 mg, or 35 mg orally disintegrating tablets (ODT) as needed for migraine attacks. The study monitors treatment over an extended period to assess ongoing safety and tolerability in a pediatric population. Throughout the study, participants will be regularly evaluated for any adverse effects, including serious events, events leading to discontinuation, and significant lab abnormalities. Safety assessments are conducted over 58 weeks, with careful monitoring to ensure participant well-being and collect comprehensive safety data.

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.