Port Jefferson Station

Researchers are evaluating the effectiveness and safety of Xeomin injections in preventing chronic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections given into muscles of the head and neck. Participants have chronic migraine diagnosed for at least 12 months and meet specific headache and migraine day criteria. The study aims to measure changes in monthly migraine days over time with Xeomin treatment. Participants will receive four treatments spaced about 12 weeks apart over a total study duration of 52 to 55 weeks. The treatments involve injections of either Xeomin or placebo solution prepared with sodium chloride. Visits occur approximately every 4 weeks, totaling 14 visits: the first, last, and four treatment visits are on-site, while the other eight visits are remote via phone or video call. During the study, participants will keep headache diaries to track migraine and headache days. Researchers will focus on the change in monthly migraine days from baseline to six months after the first injection. Safety and effectiveness are monitored throughout, with frequent assessments during both on-site and remote visits to ensure accurate tracking of migraine symptoms and any side effects.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing episodic migraine. This phase 3 clinical trial focuses on adults who experience episodic migraine, aiming to measure changes in the number of migraine days per month. Participants must have a diagnosis of episodic migraine for at least 12 months and meet specific headache frequency criteria. Participants will receive four treatments of either Xeomin or placebo injections into muscles of the head and neck, with treatments spaced about 12 weeks apart. The entire trial lasts approximately 52 to 55 weeks, beginning with a screening period of 4 to 5 weeks. There are about 14 visits in total, with the first, last, and four treatment visits conducted on-site, while the other visits are held remotely via phone or video. Throughout the study, participants will track their migraine days using a headache diary, and researchers will assess changes in monthly migraine frequency from baseline to six months after the first injection. Regular monitoring includes both in-person and remote assessments. The primary outcome focuses on the change in monthly migraine days between baseline and month six after treatment initiation.

This research aims to establish a Phase-2 master protocol framework to evaluate the safety and effectiveness of various investigational treatments for chronic weight management in adults with obesity or overweight. The study sets common entry criteria for participants across multiple specific intervention groups, called intervention-specific appendices (ISAs), which may begin independently as new treatments become available for clinical testing. The overall results will be reported after all ISAs are completed. The study involves multiple investigational drugs administered either by injection (subcutaneously) or orally. These include LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226, and placebo treatments matching the administration methods of the active drugs. Each ISA will detail the specific intervention procedures. Treatments are given according to the ISA schedules as participants are assigned to different groups. Participants will be involved from screening through treatment and monitoring phases, where their body weight stability and other health parameters are assessed. Researchers will track the number of participants allocated to each ISA during the first six weeks. Safety and efficacy will be evaluated throughout the study, which includes regular assessments and adherence monitoring. The study includes adults aged 18 to 75 with specific body mass index (BMI) criteria and weight stability prior to enrollment.

Researchers are evaluating the safety and effectiveness of targeted therapies and immunotherapy, alone or in combination, in people with metastatic colorectal cancer (mCRC) whose tumors show specific biomarkers. This open-label, exploratory Phase I/Ib study assigns participants to treatment groups based on their tumor biomarker test results. The goal is to understand how well these treatments work and how safe they are for different patient subgroups defined by biomarker status. Participants may receive various study drugs, including oral medications like Inavolisib, SY-5609, and Divarasib, or intravenous drugs such as Bevacizumab, Cetuximab, Atezolizumab, Tiragolumab, FOLFOX, and FOLFIRI. The specific treatment and schedule depend on the assigned study arm and the participant's biomarker profile. Biomarker testing is done using validated tests, including the FoundationOne Liquid CDx blood test, to guide treatment allocation. During the study, participants will be monitored for safety and treatment response over approximately 84 months, focusing on the objective response rate. Evaluations include tumor measurements using RECIST criteria, collection of tumor tissue samples for biomarker research, and regular assessments of organ function and overall health. Safety is closely tracked, and participants must be able to follow the study protocol and attend scheduled visits throughout their participation.

Researchers are evaluating a drug called sigvotatug vedotin alone and in combination with pembrolizumab, with or without chemotherapy, to determine its safety and effects in people with various advanced solid tumors. This Phase 1 study includes participants with specific cancers like non-small cell lung cancer, head and neck squamous cell cancer, HER2-negative breast cancer, esophageal cancers, ovarian cancer, and others. The trial aims to find out the side effects of sigvotatug vedotin and whether it can treat these solid tumors effectively. The study is divided into four parts. Part A focuses on finding the right dose of sigvotatug vedotin. Part B tests the safety and effectiveness of that dose. Parts C and D look at the safety and effectiveness of sigvotatug vedotin combined with pembrolizumab alone or with chemotherapy drugs carboplatin or cisplatin. Participants receive these drugs intravenously, with pembrolizumab given every 3 or 6 weeks and chemotherapy every 3 weeks depending on the drug. During the study, participants undergo tumor biopsies, physical exams, and disease assessments to monitor treatment effects. Researchers track side effects, lab abnormalities, and dose-limiting toxicities for up to 30-37 days after the last dose of sigvotatug vedotin, and for up to 3 years after pembrolizumab treatment. The study follows participants with regular safety monitoring and evaluations of tumor response throughout the trial.

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of KarXT in men and women aged 55 to 90 years who have mild to severe Alzheimer's Disease with moderate to severe psychosis related to the condition. The main goal is to compare KarXT against a placebo by measuring changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician (NPI-C) score. Participants will receive different doses of KarXT ranging from 20/2 mg to 66.7/6.67 mg daily or placebo capsules. The study is designed to compare the effects of KarXT with placebo in a parallel group format, maintaining the double-blind setup to ensure unbiased results. During the study, participants will be assessed at the start and end of treatment (up to 14 weeks) to evaluate changes in psychotic symptoms. They will undergo clinical scales such as the NPI-C and the Clinical Global Impression-Severity (CGI-S) scale. The study also requires imaging scans like MRI or CT to rule out other brain diseases. A study partner who has regular contact with the participant will be involved to support adherence and observation. Safety and efficacy will be monitored throughout the treatment period.

Researchers are investigating the safety and how the body processes a medicine called Zavegepant (PF-07930207) in children aged 6 to less than 12 years who have a history of migraine lasting at least 6 months. The study focuses on understanding how the medicine is absorbed, changed, and removed by the body in this young population. Participants must weigh more than 15 kilograms to join this Phase 1 study. All children in the study will receive a single dose of Zavegepant as a nasal spray, with the dose depending on their weight (either 5 mg or 10 mg). The medicine is given once by spraying into one nostril. This study is open-label and multicenter, meaning both researchers and participants know what treatment is given, and it is conducted at multiple locations. Participants will be involved for up to 10 weeks, during which they will have three visits to the study clinic and two follow-up phone calls. During these visits, researchers will collect blood samples at specified times to measure how much medicine is in the bloodstream and how quickly it reaches peak levels. They will also monitor safety, tolerability, and any side effects to better understand the medicine's effects in children with migraine.

Researchers are evaluating the effectiveness of a combination treatment involving adagrasib, pembrolizumab, and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. This Phase 2 trial focuses on patients with PD-L1 tumor proportion score (TPS) of 1% or higher, but less than 50%, who have not received prior systemic therapy for advanced disease. The study aims to assess how well this combination works as a first treatment option for this patient group. Participants receive adagrasib as oral tablets twice daily at a dose of 400 mg. Pembrolizumab and chemotherapy drugs (pemetrexed and either cisplatin or carboplatin) are given by intravenous infusion once every three weeks. The study includes several groups based on prior treatments and PD-L1 levels, with some participants having previously completed induction chemotherapy. Treatments are administered according to these schedules and patient eligibility. During the study, researchers monitor participants for tumor response and progression-free survival over 30 months. They use standard criteria to measure tumor size changes and disease progression. Assessments include clinical evaluations and imaging to track response to treatment. Safety and tolerability are also monitored throughout the study period to understand the effects of the combination therapy on patients.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effectiveness of RGT-419B given by mouth alone or combined with hormonal therapy in adults with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This phase I, first-in-human, open-label study focuses on patients whose cancer has progressed after prior treatment with approved CDK4/6 inhibitors plus hormonal therapy. The study aims to understand how RGT-419B behaves in the body and its potential effects when used alone or alongside hormonal treatments. Participants receive oral capsules of RGT-419B either as a single treatment or combined with hormonal therapies such as Selective Estrogen Receptor Degraders, Selective Estrogen Receptor Modulators, or Aromatase Inhibitors. The study involves escalating doses to find safe and tolerable levels, with treatment groups receiving either the monotherapy or combination therapy. The research monitors dose-limiting toxicities during cycles lasting four weeks each to evaluate safety at each dose level. During the trial, participants will undergo regular assessments including medical exams, imaging to measure tumor lesions, laboratory tests to check organ function, and monitoring for side effects. Researchers will track how many participants experience dose-limiting toxicities within each treatment cycle. Participants must be able to understand and consent to the study procedures. The focus is on determining the safe dose range and gathering information to guide future studies of RGT-419B in this patient population.

Researchers are compiling real-world results of the Intracept™ Intraosseous Nerve Ablation System, which is a commercially approved device used to treat patients with vertebrogenic pain, a cause of chronic low-back pain. The study aims to understand how this minimally invasive procedure performs in everyday medical practice for those diagnosed with vertebrogenic pain syndrome. Participants receive treatment using the Intracept™ Intraosseous Nerve Ablation device according to local instructions for use. This procedure is designed to address vertebrogenic back pain by targeting affected nerves within the bone structure. The study focuses on patients who are already scheduled for this therapy in routine clinical care. During the study, researchers will observe participants over time and measure changes in disability related to back pain using the Oswestry Disability Index, with follow-up assessments reaching up to 60 months after the procedure. The study collects data on how patients respond to the treatment in real-world settings, aiming to gather long-term outcomes and safety information.