Port Jefferson Station

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing chronic migraine. This Phase 3, randomized, double-blind, placebo-controlled trial includes an extension period and aims to measure changes in the number of monthly migraine days. Participants have chronic migraine and meet specific criteria related to headache frequency and migraine history. Participants receive Xeomin or placebo injections into muscles of the head and neck at pericranial and cervical points. The study includes two Xeomin dose groups and a placebo group during the controlled period, with all groups receiving Xeomin in the extension phase. Four treatments are given approximately 12 weeks apart over a total study duration of 52 to 55 weeks. Participants take part in 14 visits over the study period, with the first, last, and four treatment visits conducted in person and the remaining eight visits by phone or video call. Researchers collect headache and migraine data from diaries and assess changes in monthly migraine days as the primary outcome. Safety is monitored by tracking treatment-related adverse events throughout the trial.

Researchers are evaluating the use of Xeomin injections to prevent episodic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections in the muscles of the head and neck to measure changes in the number of monthly migraine days. Participants have episodic migraine with or without aura, and the study aims to assess the efficacy and safety of different Xeomin doses over time. Participants receive a series of four Xeomin or placebo injections spaced about 12 weeks apart. The study includes two experimental groups receiving different Xeomin doses and a placebo group, followed by an extension period where some participants receive Xeomin. Injections are given at specific points around the head and neck. The trial lasts approximately 52 to 55 weeks, starting with a 4 to 5 week screening period. Participants attend about 14 visits, including the first and last visits and four treatment visits conducted on-site, with other visits done remotely by phone or video call. Researchers monitor changes in monthly migraine days, headache days, and medication use, as well as any treatment-related side effects throughout the study.

This research focuses on adults with obesity or overweight and aims to evaluate the safety and effectiveness of various investigational treatments for chronic weight management. It is a Phase 2 master protocol study that uses a framework to test multiple interventions, each detailed in separate appendices. The study establishes criteria for enrolling new participants and reports results when all intervention appendices have completed. Participants may receive different investigational drugs administered either by subcutaneous injection or orally, including LY3305677, LY3841136, tirzepatide, LY3549492, and others. Each intervention-specific appendix outlines the particular treatment details and analyses. Some participants receive placebos matching the administration method of the active treatments. Treatments and analyses are conducted in parallel groups, and interventions may start independently as they become available. Throughout the study, participants undergo screening to confirm eligibility and are randomly assigned to one of the intervention groups or placebo. Researchers monitor participant allocation up to week 6. The trial emphasizes double-blind procedures, and participant involvement includes receiving study treatments and attending scheduled visits. Safety and efficacy data are collected, and the study is planned to continue until early 2028, with primary outcome measures focusing on participant allocation to interventions.

Researchers are evaluating targeted therapies and immunotherapy for people with metastatic colorectal cancer mCRC that have specific biomarkers. This open-label, exploratory Phase 11b study aims to assess the safety and effectiveness of these treatments alone or in combination. Eligible participants will be assigned to treatment arms based on their tumor biomarker test results to better understand how these therapies work in different subgroups of mCRC. Participants may receive various drug combinations including oral inavolisib, intravenous IV cetuximab, bevacizumab, atezolizumab, tiragolumab, SY-5609, divarasib, and chemotherapy regimens such as FOLFOX or FOLFIRI. Treatment cycles typically last 21 or 28 days, with dosing schedules varying across arms, including daily oral medications and IV infusions on specific days. Some arms are actively recruiting, while others are closed or not currently enrolling. During the study, participants will undergo regular assessments including tumor measurements to evaluate response, blood tests to monitor drug levels and safety, and collection of tumor tissue for biomarker research. The primary outcome is the objective response rate over about 7 years. Secondary outcomes include duration of response, disease control rate, and adverse event monitoring. Participants are followed long-term to assess treatment effects and safety, with study participation lasting up to approximately 84 months.

Researchers are evaluating a drug called sigvotatug vedotin SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy, to assess its safety and effects in people with advanced solid tumors. This Phase 1 study aims to determine the side effects and whether sigvotatug vedotin works to treat various solid tumors including lung, head and neck, breast, esophageal, skin, pancreatic, bladder, cervical, gastric, and ovarian cancers. The study is divided into four parts to explore dosage, safety, and combination treatments. Participants may receive sigvotatug vedotin alone or combined with pembrolizumab, sometimes alongside chemotherapy drugs carboplatin or cisplatin, depending on the study part. Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to further test safety and effectiveness. Parts C and D study the drug combined with pembrolizumab and possibly chemotherapy in different tumor types and treatment settings, including people who have not previously received treatment. Treatments are given intravenously, with pembrolizumab administered every 3 or 6 weeks and chemotherapy every 3 weeks. During the study, participants undergo tumor biopsies, clinical evaluations, and monitoring for side effects, including blood tests and safety assessments. Researchers track adverse events, lab abnormalities, and dose-limiting toxicities up to 30-37 days after treatment, with some follow-up extending up to 3 years. They also measure tumor response using standard criteria and monitor survival and drug levels in the body. Participants will have regular visits for treatment and assessments throughout the study duration, which may last several years.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 years who have mild to severe Alzheimers Disease AD with moderate to severe psychosis related to AD. This Phase 3 study aims to compare KarXT with a placebo to see how well it works in treating psychosis symptoms associated with AD, focusing on changes in hallucinations and delusions. Participants will receive either KarXT capsules at varying doses or placebo capsules in a randomized, double-blind setup. The treatment period lasts up to 14 weeks, during which participants take the assigned capsules daily. The study design includes two groups running in parallel, with neither participants nor researchers knowing who receives the drug or placebo. During the study, participants will undergo assessments including the Neuropsychiatric Inventory-Clinician NPI-C focusing on hallucinations and delusions, Clinical Global Impressions-Severity scale, and other related scales to measure psychosis symptoms and caregiver distress. Safety and efficacy will be monitored throughout, with evaluations at baseline and at the end of treatment. The entire participation period extends up to 14 weeks.

Researchers are studying the safety and how the body processes the medicine called Zavegepant PF-07930207 in children aged 6 to less than 12 years who have a history of migraine. The study focuses on understanding how the body changes and removes this medicine after taking it. Participants must have had migraines for at least 6 months and weigh more than 15 kilograms. All children in the study will receive a single dose of Zavegepant as a nasal spray, with the dose depending on their weight. Each participant will get one spray into one nostril. This is an open-label study, meaning everyone receives the study medicine, and the effects of different doses will be observed. The study lasts up to 10 weeks. During the study period, participants will attend 3 clinic visits and have 2 follow-up phone calls. Researchers will monitor the medicines concentration in the blood at specific times after dosing. They will also track any side effects and changes in vital signs, lab results, and mental health. The main outcomes involve measuring how much and how quickly the medicine appears in the blood.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of RGT-419B in people with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This phase I, open-label study includes participants whose disease has progressed after prior treatment with a CDK46 inhibitor plus hormonal therapy. The study is focused on patients with Stage III locally advanced unresectable or Stage IV metastatic breast cancer. Participants receive RGT-419B either alone as monotherapy or combined with hormonal therapy, including selective estrogen receptor degraders, modulators, or aromatase inhibitors. The study uses escalating oral doses in a sequential design to assess safety and drug behavior. This first-in-human trial includes two experimental arms for comparison between monotherapy and combination therapy. During the study, participants are monitored for dose-limiting toxicities over a 4-week cycle and followed for an average of one year to assess overall safety, drug levels, tumor response, and heart rhythm changes. Researchers collect blood and urine samples for pharmacokinetic analysis and evaluate tumor size using RECIST criteria. The study involves regular assessments to monitor treatment effects and safety throughout participation, which may last up to several years.

Researchers are compiling real-world outcomes of the commercially approved Intracept2 Intraosseous Nerve Ablation Systems for treating patients diagnosed with vertebrogenic pain, including those with chronic low-back pain and vertebrogenic pain syndrome. This observational study aims to gather data on how this minimally invasive device performs in routine clinical use. Participants who are scheduled for treatment with the Intracept2 Intraosseous Nerve Ablation System will be observed following their procedure according to local instructions. The study focuses on patients receiving this commercially approved device without altering their treatment plan. Throughout the study, participants will have their disability levels assessed using the Oswestry Disability Index ODI from baseline up to 60 months after the procedure. Data collected will help understand the long-term effects of the device on pain and disability. The total duration of participation may extend up to five years post-treatment.

This research aims to evaluate the long-term safety of rimegepant in children and adolescents aged 6 to under 18 years for the acute treatment of migraine, including migraines with or without aura. The study focuses on understanding the safety profile of this medication when used over an extended period in this younger population. Participants receive rimegepant orally in doses of 75 mg, 50 mg, or 35 mg as orally disintegrating tablets. The study is open-label and single-group, meaning all participants receive the active drug. The treatment period lasts up to 58 weeks, during which the medication is assessed for safety and tolerability. Throughout the study, participants are monitored for adverse events, including serious side effects and lab abnormalities. Researchers track the frequency and severity of these events, including any liver-related issues. The study includes blood sampling and requires participants to distinguish migraine attacks from other headaches. The total participation spans up to 58 weeks to ensure comprehensive safety data collection.