Swidnik

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating BHV-7000 as a treatment for adults with refractory focal onset epilepsy, a form of epilepsy that does not respond to standard anti-seizure medications. The study aims to determine if BHV-7000 can reduce seizure frequency and assess its safety and tolerability. This Phase 23 clinical trial is sponsored by Biohaven Therapeutics Ltd. and involves participants aged 18 to 75 years with a diagnosis of focal epilepsy lasting at least one year and resistant to previous treatments. The trial consists of two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000 once daily or a matching placebo. After completing Part A, participants may enter Part B, which involves randomization to either 75 mg of BHV-7000 once daily or placebo. Both parts are blinded, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment periods. Participants will keep accurate seizure diaries throughout the study to track seizure frequency. Researchers will monitor safety by recording adverse events and laboratory abnormalities from Week 8 to Week 20 in both parts. The main outcome measured in Part B is the change in average seizure frequency over 28 days compared to baseline. Secondary outcomes include the percentage of participants with significant seizure reduction and seizure freedom during the study. The total participation duration includes treatment and follow-up assessments over several weeks.

Researchers are evaluating the effectiveness of a single dose of Staccato alprazolam compared with a placebo to quickly stop prolonged seizure episodes in people aged 12 years and older with stereotypical prolonged seizures. The study aims to determine if the treatment can stop seizures within 90 seconds and prevent recurrence for up to 2 hours after administration. This is a phase 3, randomized, double-blind clinical trial sponsored by UCB Biopharma SRL. Participants are randomly assigned to receive one dose of either Staccato alprazolam or placebo by inhalation during the treatment period. The study involves a parallel-group design with one treatment administration. Participants are observed for the treatments effect on seizure cessation and recurrence for up to 6 hours. During the study, participants and their caregivers will be monitored for seizure activity and safety outcomes. Various assessments include measuring treatment success within 90 seconds and seizure recurrence at 2, 4, and 6 hours after treatment. Safety is tracked through adverse event monitoring, with follow-up extending to 19 weeks after treatment. The total participation duration is based on these assessments and monitoring periods.

Researchers are evaluating the investigational drug omecamtiv mecarbil to see if it can lower the risk of serious effects related to heart failure, such as hospitalization, heart transplantation, or death, in patients with symptomatic heart failure and severely reduced ejection fraction. This phase 3 trial aims to assess both the effectiveness and safety of the drug compared to placebo in reducing cardiovascular events including death, heart failure events, left ventricular assist device implantation, cardiac transplantation, and stroke. Participants will be randomly assigned to receive either omecamtiv mecarbil or a placebo. Those in the omecamtiv mecarbil group will take an oral tablet twice daily at a dose based on their blood drug levels 25, 37.5, or 50 mg. The placebo group will receive matching tablets twice daily. The study will continue until at least 850 participants experience a heart failure event or cardiovascular death. An interim analysis will be performed when about 67% of these events have occurred. The total estimated participation duration is up to 3 years. During the trial, participants will be regularly monitored for cardiovascular events, hospitalizations, and other health outcomes. Researchers will measure the time to first cardiovascular death or heart failure event among other secondary outcomes such as stroke and overall survival. Safety will be carefully tracked throughout the study. Participants adherence to the study medication and health status will be assessed at scheduled visits over the course of the study.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.