Mangaluru

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating the safety and effectiveness of adding KarXT (Xanomeline/Trospium Chloride) to standard treatment for mania in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind study focuses on individuals experiencing acute manic episodes, with or without mixed features, who are already taking lithium, valproate, or lamotrigine. The study aims to measure changes in mania symptoms using the Young Mania Rating Scale at Week 5. Participants will be randomly assigned to receive either KarXT or a placebo alongside their stable dose of lithium, valproate, or lamotrigine. The doses of these medications are specified and given on set days during the study. Only those with stable mood stabilizer doses for at least two weeks prior to screening, and valproate treatment for at least seven months, are eligible. The treatment period lasts for 5 weeks. During the study, participants will be closely monitored through psychiatric evaluations and clinical assessments. Researchers will assess mania severity, safety, and any side effects. The main outcome is the change from baseline in the Young Mania Rating Scale score at Week 5. Participants’ physical health, including liver function and risk of urinary or gastrointestinal issues, will also be monitored to ensure safety throughout the trial.

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are evaluating the effectiveness, safety, and tolerability of remibrutinib compared to a placebo in adults with Generalized Myasthenia Gravis (gMG) who are already receiving stable standard-of-care treatment. This Phase III study is randomized, double-blind, placebo-controlled, and involves multiple centers. The study aims to provide new insights into treatment options for people living with gMG. Participants will be randomly assigned in equal numbers to receive either remibrutinib or a placebo during the Core Part, which lasts 6 months and is double-blinded. After this, there is an Extension Part lasting up to 60 months where all participants may receive open-label remibrutinib. The study treatments are administered according to the study protocol, and the trial compares the active drug with placebo to monitor their effects. During the study, participants will be assessed regularly, including measuring changes in their daily living activities affected by myasthenia gravis over six months. Researchers will monitor safety, tolerability, and adherence to treatment. The total participation can extend up to 66 months, including the core and extension periods, with ongoing evaluations and safety follow-up to understand the long-term effects of remibrutinib.

Researchers are evaluating the effects of a medicine called rimegepant in adolescents aged 12 to less than 18 years who have frequent migraine attacks. Participants must have a history of migraine for at least 6 months, experience 15 or more headache days per month including 8 or more migraine days, and untreated migraine attacks lasting 4 to 72 hours. This Phase 3 study aims to assess the safety and effectiveness of rimegepant for migraine prevention in this age group. In the first part of the study, about half of the participants will receive a rimegepant tablet every other day, and the other half will receive a matching placebo tablet every other day. This phase will last for 3 months and is double-blind and placebo-controlled. In the second part, all participants who continue will receive rimegepant every other day for 1 year to evaluate long-term safety. Tablets are orally disintegrating and taken on or under the tongue. Participants will have up to 19 visits at the study clinic, approximately every 4 weeks, with some visits possibly occurring every 2 to 8 weeks. Home health visits may also take place. Each visit includes a health check and blood sample collection. Participants will complete a daily diary to record their migraine attacks. The main outcome measured is the number of migraine days per month over 12 weeks.

This research aims to evaluate how well and how safely rimegepant works when taken during the peri-menstrual period to prevent menstrual migraine attacks in women with this condition. The study focuses on women aged 18 to 45 who have a history of menstrual migraines and regular menstrual cycles. It is a Phase 3 clinical trial comparing rimegepant to a placebo. Participants will receive either rimegepant 75 mg oral disintegrating tablets or matching placebo tablets for 7 days during the peri-menstrual period. In addition, they may use rimegepant or standard care medications as needed for acute migraine treatment. The study is double-blind and parallel group, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment phase. During the study, researchers will monitor the average change from baseline in the number of migraine days occurring per 5-day peri-menstrual period over five menstrual cycles. Participants will be assessed regularly to track migraine frequency, safety, and medication use. The total study duration covers multiple menstrual cycles to observe effects over time and ensure participant safety.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.