Mooresville

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 how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.

Researchers are evaluating the addition of a stem cell transplant with melphalan after chemotherapy with daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) compared to Dara-VCD chemotherapy alone for patients newly diagnosed with amyloid light chain (AL) amyloidosis. This phase III trial aims to assess outcomes such as major organ deterioration progression-free survival, overall survival, organ response rates, and quality of life. The study also investigates minimal residual disease negativity and treatment-related side effects. Participants initially receive induction therapy with Dara-VCD drugs over a series of 28-day cycles, including daratumumab and hyaluronidase-fihj subcutaneously, bortezomib subcutaneously, cyclophosphamide orally or intravenously, and dexamethasone orally or intravenously. After induction, those with a partial response or better are randomized to one of two consolidation arms: either continued Dara-VCD chemotherapy or high-dose melphalan chemotherapy followed by autologous stem cell transplant. Following consolidation, patients receive maintenance daratumumab and hyaluronidase-fihj therapy every 28 days for up to 18 cycles, unless the disease progresses or unacceptable toxicity occurs. Throughout the study, participants undergo multiple assessments including CT, MRI, or PET-CT scans, fat pad biopsies, echocardiography, bone marrow aspiration and biopsies, and blood and urine sample collections at regular intervals. Patient-reported outcomes related to physical function, fatigue, and symptoms are collected using standardized questionnaires. After completing study treatment, patients are followed up every 3 to 6 months for up to 4 years to monitor progression and overall health.

Researchers are comparing two monoclonal antibody treatments, rituximab and mosunetuzumab, for patients with follicular lymphoma who have a low tumor burden and have not received prior systemic therapy. The study aims to evaluate which treatment provides better progression-free survival and overall outcomes. This phase III randomized clinical trial also assesses overall survival, response rates, event-free survival, and treatment-related toxicities over time. Participants are randomly assigned to receive either rituximab or mosunetuzumab. Those in the rituximab group receive intravenous rituximab on day 1 of the first cycle and subcutaneous rituximab with hyaluronidase on several days, repeating every 56 days for up to five cycles if tolerated. The mosunetuzumab group receives the drug subcutaneously on specified days every 21 days for up to eight cycles. During treatment, patients undergo CT and/or PET/CT scans and blood sample collections to monitor disease and health. After completing treatment, participants are followed every six months for five years, then annually up to a total of ten years. The study includes regular imaging and blood tests to assess disease progression, response, and safety. The main outcomes measured are progression-free survival milestones, with other key measures including overall survival and adverse events. Specimens are also collected for future research to better understand the disease and treatment effects.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating whether adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups: one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigator’s discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients’ health and quality of life.

Diabetic foot ulcers (DFUs) are a common and serious complication for people with diabetes, often challenging to heal with standard treatments. This research evaluates how well a new product, Amnion-Intermediate-Chorion (AIC), made from dehydrated human placental tissue, works alongside standard care compared to standard care alone in closing these ulcers. The trial is a Phase 4, randomized study focused on improving healing outcomes for diabetic foot ulcers. Participants will receive standard care, which includes cleaning, removing damaged tissue, managing moisture, and offloading pressure from the ulcer. One group will receive only this standard care weekly for up to 12 weeks or until the ulcer closes. The other group will receive the same standard care plus weekly application of the AIC sheet product during the same period. This treatment phase begins after a screening visit and continues based on ulcer healing or treatment duration limits. During the study, participants will attend regular visits to assess ulcer healing, pain changes, wound size, and any side effects. Researchers will measure how many ulcers fully close within 1 to 12 weeks and track the time it takes to heal. Quality of life changes will also be evaluated. The study includes monitoring safety and effectiveness through these assessments, with participants involved for up to 12 weeks of treatment.

Researchers are evaluating the combination of bevacizumab and osimertinib versus osimertinib alone as an initial treatment for patients with advanced non-small cell lung cancer (NSCLC) that has spread beyond the lungs and has specific mutations in the EGFR gene. This phase III trial aims to understand if adding bevacizumab, which inhibits blood vessel growth to tumors, can control cancer longer and improve survival compared to osimertinib alone, which blocks EGFR involved in tumor cell growth. Participants are randomly assigned to one of two groups. One group receives daily oral osimertinib every 21 days, while the other group receives the same osimertinib dose plus an intravenous bevacizumab infusion every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, patients undergo various imaging tests such as echocardiography, multigated acquisition scan, computed tomography, and possibly magnetic resonance imaging, along with blood and urine sample collections. After treatment ends, patients are followed every three months for up to 10 years to monitor their health and disease status. The main outcome measured is progression-free survival, tracking the time until the cancer worsens or death occurs. Secondary outcomes include overall survival, response rates, and effects on central nervous system progression. Safety is also assessed through adverse event monitoring. This long-term follow-up helps researchers understand the lasting effects of the treatments.

Researchers are evaluating whether observation alone is as effective as continuing treatment with pembrolizumab in preventing cancer recurrence in patients with early-stage triple-negative breast cancer (TNBC) who achieved a complete response after receiving chemotherapy combined with pembrolizumab before surgery. This phase III trial aims to compare these approaches in terms of recurrence-free survival, quality of life, and overall value of care. The study also examines side effects, survival rates, and financial impacts associated with the treatments. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab treatment intravenously every 3 or 6 weeks for 27 weeks, while the other group undergoes observation without additional treatment during this period. Both groups will have tumor biopsies and blood samples collected, along with imaging tests like mammography, breast ultrasound, or MRI during follow-up. Throughout the study, participants will be monitored for cancer recurrence, survival, adverse events, and quality of life using questionnaires and assessments. Blood and tumor samples will help track biological markers. The primary outcome is recurrence-free survival over up to 10 years. Secondary outcomes include adverse event rates, overall survival, and local recurrence. Additional evaluations cover financial costs, work productivity, and patient-reported side effects. The total participation may involve long-term follow-up and several assessments over approximately 27 weeks and beyond.