Spring Hill

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine HAV, and a pneumococcal conjugate vaccine PCV which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants immune responses by measuring antibodies against varicella zoster virus VZV and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

Researchers are evaluating the safety and effectiveness of atogepant, a medication approved for adults with migraine, in children and teens aged 6 to 17 who have a history of episodic migraine. This Phase 3 study addresses the limited approved treatments available for pediatric migraine sufferers and aims to better understand atogepants impact on this younger population. Participants will be randomly assigned to one of six groups based on age and dosage. Children aged 6 to 11 will participate in a pharmacokinetic substudy to determine the appropriate dose before receiving either placebo, low-dose, or high-dose atogepant tablets once daily for 12 weeks. Teens aged 12 to 17 will be randomized to receive placebo, low-dose, or high-dose atogepant tablets daily for 12 weeks. After this period, participants may have a follow-up visit 4 weeks after their last dose or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular hospital or clinic visits for medical evaluations, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in the number of migraine and headache days, medication use, quality of life, and migraine-related disability. Safety will be monitored through adverse event reporting up to 16 weeks. The total study duration includes the 12-week treatment period with possible extension and follow-up assessments.

The trial investigates treatment options for adults with locally advanced pancreatic adenocarcinoma that cannot be removed by surgery. It compares the effects of delivering the chemotherapy drug gemcitabine directly into the artery versus continuing standard intravenous chemotherapy with gemcitabine plus nab-paclitaxel, following initial radiation therapy. The purpose is to evaluate overall survival and other outcomes in this patient group under a phase 3 clinical study. All participants first receive induction therapy consisting of intravenous gemcitabine plus nab-paclitaxel along with stereotactic body radiation therapy SBRT over about four months. Those who remain eligible are then randomly assigned to one of two groups one group receives intra-arterial gemcitabine via the RenovoCath device every other week for up to 16 weeks, while the other group continues intravenous gemcitabine and nab-paclitaxel on a 28-day cycle for 16 weeks. After this, both groups may receive intravenous gemcitabine plus nab-paclitaxel or oral capecitabine until their disease progresses. Participants undergo regular assessments including imaging, laboratory tests, and evaluations of health-related quality of life and neuropathy. Researchers monitor overall survival for up to five years, as well as progression-free survival, response rates, safety, and tolerability. The study includes follow-up for survival outcomes and adverse events, with monitoring continuing for up to five years after treatment.

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.

Migraine is a common neurological disorder that causes moderate to severe headache attacks, often with nausea, vomiting, and sensitivity to light and sound. This study is evaluating the safety and effectiveness of ubrogepant, a drug approved for adults, for the acute treatment of migraine in children and adolescents aged 6 to 17 years. The trial includes two participant groups a pharmacokinetic PK cohort for dose analysis in younger children and a main study cohort involving randomized treatment with different ubrogepant doses or placebo. Participants aged 6 to 11 years in the PK cohort will receive one of two doses of ubrogepant to determine dosing for the main study. In the main study, children aged 6 to 11 and adolescents aged 12 to 17 will be randomly assigned to low or high doses of ubrogepant or placebo, with a one in three chance of receiving placebo. For qualifying migraine attacks, participants will take oral tablets of the assigned study treatment, with the option of a second dose or rescue medication at least two hours later if headaches remain moderate or severe. Participants will be involved for up to six months and will attend regular hospital or clinic visits. Researchers will monitor treatment effects using medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome measured is the percentage of participants achieving pain freedom two hours after the initial dose. Safety, tolerability, and pharmacokinetic data will also be collected to understand ubrogepants effects in this younger population.

Researchers are evaluating AVM0703, an immunomodulatory drug given as a single intravenous infusion, in patients aged 12 to 95 years with various lymphoid malignancies, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia. This open-label Phase 12 study aims to understand its safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with relapsed or refractory disease who have undergone or are ineligible for prior therapies. The study is sponsored by AVM Biotechnology Inc.