Colton

Researchers are evaluating the long-term safety and tolerability of intermittent use of elismetrep in adults who experience acute migraine attacks. This Phase 3 study aims to monitor adverse events and overall safety during an average of one year of treatment. The study is conducted by Kallyope Inc. and compares two doses of elismetrep with a placebo using a randomized, triple-blind design. Participants will receive oral doses of elismetrep at either 10 mg or 20 mg, or a matching placebo. The study focuses on intermittent use during acute migraine episodes. Participants must have completed a prior acute treatment trial of elismetrep and meet compliance criteria. Treatment and assessments continue through the study duration, averaging one year. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, and events leading to discontinuation. They will use a personal smartphone to complete eDiary check-ins and questionnaires, including assessments at 2 and 4 hours post-dose during migraine attacks. Safety and tolerability data will be collected throughout, with study participation lasting approximately one year.

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating the effects of elismetrep, an oral drug, compared with a placebo for the acute treatment of migraine in adults aged 18 to 75. This phase 3, double-blind, randomized study is conducted at multiple centers to assess the drugs safety, tolerability, and effectiveness in relieving migraine symptoms quickly. Participants receive either 10 mg or 20 mg of elismetrep or a placebo orally as part of the trial. The study uses a parallel design where participants are randomly assigned to one of these groups and neither the participants nor the researchers know which treatment is given until the study ends. During the trial, participants will be monitored for migraine pain relief and freedom from bothersome symptoms two hours after dosing, among other outcomes. Researchers will also assess pain relief at various time points, use of rescue medication, and safety by tracking any adverse events. Participants will complete questionnaires and use an eDiary app to record their experiences. The study is expected to last until February 2027.

Researchers are evaluating the use of rimegepant for intermittent prevention of menstrual migraine in women aged 18 to 45 who experience migraine attacks related to their menstrual cycle. This Phase 3, double-blind, randomized study compares rimegepant with placebo to assess its efficacy and safety during the peri-menstrual period. The study focuses on migraine frequency and severity in women with a history of menstrual migraine and regular menstrual cycles. Participants receive either rimegepant 75 mg orally disintegrating tablets for 7 days during each peri-menstrual period or a matching placebo, along with standard care for acute migraine treatment as needed. The study treatment cycles are repeated over 5 menstrual cycles in the double-blind treatment phase. The study also includes an acute treatment dosing option with rimegepant as needed. During the study, participants will be monitored for changes in the number of migraine and headache days, use of migraine medications, and functional disability related to migraine. Cognitive function is also assessed. Researchers will conduct evaluations over 5 months, covering 5 menstrual cycles, and measure outcomes related to migraine frequency and severity during the peri-menstrual period. Safety and tolerability will be closely monitored throughout the study.

Researchers are evaluating adaptive interventions to increase long-term use of buprenorphine in adults with probable opioid use disorder OUD who come to the emergency department ED. This trial uses a two-stage, sequential multiple assignment randomized design to develop the most effective approach. The study aims to compare different treatment strategies to see which helps maintain buprenorphine use longer and delays overdose, self-harm, or death. The trial includes several treatment options. Initially, participants receive either the CA Bridge Model with Substance Use Navigator SUN assisted treatment initiation and linkage to care or the same approach plus immediate telehealth connection to an outpatient provider SUNTeleBridge. Those who do not respond within 90 days are randomized to receive ongoing buprenorphine treatment by an ED-based interim treatment team ED-ITT alone or with added behavioral health support ED-ITTBHS for up to 3 months. Responders receive no further active intervention unless they return to the ED or report stopping buprenorphine. Participants will be monitored for buprenorphine prescription fills over 6 months and tracked for overdose, suicide, self-harm, or death events. Researchers will review prescription records, patient reports, and ED visits to assess treatment adherence and outcomes. The study involves regular follow-up and behavioral health assessments to evaluate the effectiveness of different adaptive treatment strategies over one year.

Researchers are evaluating the use of apixaban compared to aspirin to prevent stroke or death in patients who have had a recent intracerebral hemorrhage ICH and also have atrial fibrillation AF. This phase III randomized, double-blinded trial aims to determine if apixaban is superior in preventing any type of stroke or death, as well as if it leads to better functional recovery measured by the modified Rankin Scale. The study will enroll 700 patients and follow them for 12 to 36 months to assess these outcomes. Participants will be randomly assigned to receive either apixaban or aspirin. Apixaban dosing is typically 5 mg twice daily, with a reduced dose of 2.5 mg twice daily for those meeting specific criteria such as older age, lower body weight, or certain medication use. Aspirin is given once daily at a dose of 81 mg. The study includes a treatment period after recent ICH, with careful monitoring for safety and efficacy. During the study, participants will undergo regular assessments including evaluation of stroke occurrence, death, and changes in functional status using the modified Rankin Scale. Safety and adherence will be monitored throughout the follow-up period, which ranges from 12 months up to 3 years. The research team will collect data to understand the benefits and risks of apixaban versus aspirin in this patient population.

This research aims to evaluate whether taking 2 grams of oral azithromycin before labor induction in pregnant women during their third trimester can reduce maternal and newborn infections. The trial focuses on women undergoing induction of labor, a common procedure that has increased recently. Researchers want to see if this antibiotic can help prevent infections like chorioamnionitis, endometritis, and wound infections, improving health outcomes and potentially reducing hospital stays and costs. Participants will be randomly assigned to one of two groups one will receive 2 grams of azithromycin four 500 mg tablets once before labor induction, and the other will receive a placebo of four magnesium oxide tablets once before induction. This is a double-blinded study, meaning neither participants nor researchers know who receives the antibiotic or placebo during the trial. Women in the study will be monitored from the time of labor induction through delivery and for six weeks postpartum. Researchers will assess infection rates using a composite infection measure and track any infections that occur during this period. Safety and health outcomes for both mothers and newborns will be carefully followed to understand the impact of azithromycin given before labor induction.

Researchers are evaluating the FebriDx test to determine how well it distinguishes between bacterial and non-bacterial causes in children aged 2 to 11 years who have a fever and suspected acute respiratory infection. This observational study involves febrile pediatric patients presenting to emergency departments, urgent care centers, or primary care offices. The goal is to assess the tests ability to detect a bacterial systemic immune response compared to expert clinical adjudication using a clinical reference algorithm including pathogen detection and immune response measures. The study involves using the FebriDx device, a rapid lateral flow immunoassay that detects elevated levels of host response proteins Myxovirus resistance protein A MxA and C-reactive protein CRP from a fingerstick blood sample. Children suspected of acute respiratory infection will undergo the FebriDx test during a single visit. The study is blinded and observational without experimental treatments or placebo groups. Participants will be assessed once at enrollment with the FebriDx test and clinical data collection. Researchers will review clinical signs, symptoms, and results from pathogen detection tests such as bacterial culture or multiplex PCR to adjudicate infection status. Follow-up includes a 7-day period to monitor outcomes. The main outcome measure is the performance of the FebriDx test in identifying bacterial infections on the day of testing.

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 effect of seltorexant as an add-on treatment to antidepressants in adults and elderly people with major depressive disorder who also have insomnia symptoms and have not responded well to their current antidepressant therapy with SSRIs or SNRIs. This Phase 3 study aims to understand how well seltorexant works, its safety, and its ability to maintain improvement compared with a placebo. Participants in part 1 of the study will receive either seltorexant or a matching placebo once daily for 6 weeks, alongside their usual SSRI or SNRI antidepressant. Those who complete part 1 and meet criteria for part 2, plus new participants entering directly into part 2, will receive seltorexant during an open-label induction and stabilization phase. Participants who respond well will then enter a double-blind maintenance phase, receiving either seltorexant or placebo daily, continuing their baseline antidepressant throughout. During the study, participants will be monitored through rating scales measuring depression severity, sleep disturbance, and patient health questionnaires at baseline and specified days up to two years and ten months. Researchers will assess changes in depression symptoms and time to relapse, along with safety and tolerability. Participants will be followed through treatment phases and post-treatment periods to evaluate the maintenance of effects and overall safety.