Livingston

Researchers are studying the effects of LP352 in children and adults with Dravet Syndrome, a condition characterized by seizures. This randomized, double-blind, placebo-controlled Phase 3 study aims to assess the efficacy, safety, and tolerability of LP352 in reducing seizures. The trial is sponsored by Longboard Pharmaceuticals and includes participants aged 2 to 65 years. Participants will be randomly assigned to receive either LP352 or a matching placebo, administered orally or through a feeding tube. The study includes a Screening phase, a Titration period where doses are gradually increased to the highest tolerated level, followed by a Maintenance period, then a Taper period to reduce the dose, and finally a Follow-Up phase. The entire study will last about 24 months. During the trial, participants will be closely monitored for seizure frequency and safety outcomes. Researchers will collect data on seizure counts, medication adherence, and any side effects. The primary measure is the change in the frequency of motor seizures compared to baseline over up to 15 weeks. Participants will also undergo regular visits for evaluation, and safety will be observed up to 21 weeks. The study aims to provide detailed information on how LP352 affects seizures and overall tolerability in this population.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk A/S, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist: one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.

Researchers are evaluating the real-world experience of participants treated with BRIUMVI4 (ublituximab-xiiy) for relapsing multiple sclerosis (RMS). The study aims to assess the safety, effectiveness, and overall treatment experience of this medication in everyday clinical practice. The trial is observational, focusing on patients who have been prescribed BRIUMVI and tracking their outcomes over time. Participants in this study will receive BRIUMVI4 as an intravenous (IV) infusion specifically for RMS treatment. The study includes participants who have not previously received BRIUMVI infusions before the study begins, allowing observation from the start of their treatment. This approach helps understand how the medication performs outside of controlled clinical trial settings. During the study, researchers will monitor participants for up to 96 weeks, measuring the annualized relapse rate (ARR) to evaluate disease activity. They will also track adverse events, serious adverse events, and infusion-related reactions at each infusion visit. Participants will undergo regular assessments to capture their health status and any side effects, providing a comprehensive view of treatment safety and patient experience over nearly two years.

Researchers are evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage (stage I and II) classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments: some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

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 2/3 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 drug LP352 in children and adults who have developmental and epileptic encephalopathies (DEE), including Lennox-Gastaut Syndrome (LGS) and other types of DEE. This phase 3, randomized, double-blind, placebo-controlled, multicenter study aims to assess the effectiveness, safety, and tolerability of LP352 for reducing seizures in this population. The study is sponsored by Longboard Pharmaceuticals and will last about 24 months. Participants will be randomly assigned to receive either LP352 or a matching placebo. LP352 is given orally or through a feeding tube (G-tube or PEG tube). The study includes several phases: a Screening phase, a Titration period where the dose is gradually increased to the highest tolerated level, a Maintenance period to continue treatment, followed by a Taper period to reduce the dosage and a final Follow-Up phase. During the trial, participants will be monitored for seizure frequency, safety, and tolerability. Seizure counts will be recorded to measure change from baseline over about 15 weeks. Participants and caregivers will complete diaries to track seizures and treatment adherence. Safety assessments will be conducted up to 21 weeks. The total participation time covers screening through follow-up, lasting roughly two years.

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.

Researchers are evaluating a new schedule of alternating cycles of chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab alone) as the first treatment for patients with advanced lung or head and neck cancers. This phase II study aims to see if less frequent chemotherapy during the induction phase can effectively control the cancer while preserving quality of life. The trial also monitors safety and response rates over time. The study has three groups based on cancer type. Each group receives alternating cycles: combination chemoimmunotherapy cycles consisting of drugs like carboplatin, paclitaxel, pemetrexed, or 5-fluorouracil with pembrolizumab, followed by cycles of pembrolizumab alone. The number of cycles varies by group, with up to four or six cycles during induction. After induction, maintenance therapy with pembrolizumab alone or combined with pemetrexed continues for up to two years. Participants will have regular assessments including imaging and laboratory tests before and during treatment to measure tumor response and monitor side effects. Researchers will track how many patients complete the induction therapy cycles and evaluate overall response rates at 6 weeks. Safety is monitored throughout the study, which can last up to three years for progression and adverse event follow-up. Patients will provide informed consent and be closely monitored during the trial.