Lexington, KY Paid Clinical Trials

Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy. Read Less

This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability. Read Less

Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Read Less

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization. Read Less

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first. Read Less

This study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study. Read Less

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG). Read Less

Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use. A mobile app has been developed that uses GPS tracking to determine when individuals visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location. The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("TRAC-ER") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data. Read Less

The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen. Read Less

This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy. Read Less

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma Read Less

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01). Read Less