Harris County

Researchers are evaluating MK-2214, a study treatment designed to slow brain changes in people with early Alzheimers disease AD. AD is a form of dementia that causes memory loss, communication difficulties, and challenges in decision-making, affecting daily tasks. This phase 2 trial aims to determine if MK-2214 slows the spread of tau protein in the brain compared to a placebo, as well as to assess the safety and tolerability of MK-2214. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusion every 4 weeks during the study. The study uses a parallel design with quadruple masking to compare the effects of the study drug versus placebo over a period of up to approximately 23 months. Both groups receive infusions on the same schedule to maintain the studys integrity. During the study, participants will undergo brain scans including positron emission tomography PET to measure tau protein levels and other assessments such as cognitive and daily living function tests. Researchers will monitor adverse events and treatment discontinuations throughout the study, which lasts up to about 26 months. These assessments help determine the impact of MK-2214 on disease progression and safety in individuals with early AD.

Researchers are evaluating the long-term safety and tolerability of intermittent use of elismetrep in adults who experience acute migraine attacks. This Phase 3 study aims to monitor adverse events and overall safety during an average of one year of treatment. The study is conducted by Kallyope Inc. and compares two doses of elismetrep with a placebo using a randomized, triple-blind design. Participants will receive oral doses of elismetrep at either 10 mg or 20 mg, or a matching placebo. The study focuses on intermittent use during acute migraine episodes. Participants must have completed a prior acute treatment trial of elismetrep and meet compliance criteria. Treatment and assessments continue through the study duration, averaging one year. During the trial, participants will be monitored for any treatment-emergent adverse events, serious adverse events, and events leading to discontinuation. They will use a personal smartphone to complete eDiary check-ins and questionnaires, including assessments at 2 and 4 hours post-dose during migraine attacks. Safety and tolerability data will be collected throughout, with study participation lasting approximately one year.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate, delivered via a multidose dry powder inhaler with an electronic module, in participants aged 12 years and older with asthma. This Phase 3 trial aims to compare this combination treatment to fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. The study also assesses different dosing schedules, safety, tolerability, and pharmacokinetics of these inhalers. Participants will be randomly assigned to one of four groups receiving either the combination inhaler, fluticasone propionate inhaler, albuterol sulfate inhaler, or placebo, all with integrated electronic modules. Treatments are administered over a 4-week period with dosing four times daily. Pharmacokinetic assessments will be conducted after a single dose administration. The study is double-blind and placebo-controlled, with a parallel group design. Throughout the approximately 10-week study period, including screening and treatment, participants will undergo evaluations including lung function tests measuring forced expiratory volume in one second FEV1, asthma control questionnaires, and safety assessments. Researchers will monitor treatment-emergent adverse events and measure blood concentrations of the inhaled drugs. The study includes electronic monitoring of inhaler use and collects data at baseline, during treatment, and at week 4, with follow-up to assess efficacy and safety.

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with advanced urothelial cancer that has spread locally or to other parts of the body. This phase III trial focuses on patients whose cancer has not responded to prior anti-PDL1 therapy. The study aims to compare overall survival, progression-free survival, response rates, duration of response, treatment side effects, and quality of life between the new combination therapy and usual chemotherapy care. Participants are randomly assigned to one of two treatment groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in 21-day cycles for up to six cycles or until disease progression or unacceptable side effects. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 every 21 days for up to 35 cycles or two years, unless disease progresses or side effects become unacceptable. Both groups undergo blood tests and imaging scans like CT or MRI throughout the study. During the trial, participants will have regular assessments including blood sample collection and imaging to monitor their cancer status and treatment effects. Researchers will also evaluate patient-reported quality of life and fatigue at multiple time points up to 12 months. After completing treatment, participants are followed up 30 days later and then annually for five years to track survival and health outcomes. This comprehensive approach helps researchers understand both the clinical outcomes and the impact on patients well-being over time.

This research aims to evaluate the effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

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 evaluating the effectiveness and safety of a new drug called GSK3862995B in adults with bronchiectasis, a chronic lung disease. This Phase 2 study also examines how the body processes the drug and checks for any immune reactions. Participants will be randomly assigned to receive one of two doses of GSK3862995B or a placebo to compare their effects on bronchiectasis. Participants will receive either Dose Level 1 or Dose Level 2 of GSK3862995B, or a matching placebo. The study uses a double-blind, randomized design, meaning neither participants nor researchers know who gets which treatment. The treatment period lasts up to 48 weeks, during which participants receive repeated doses. The study also includes assessments up to 72 weeks to monitor safety and immune responses. During the trial, participants will undergo evaluations including lung function tests, quality-of-life questionnaires, and monitoring of respiratory symptoms. Researchers will track the number of lung exacerbations, serious adverse events, laboratory tests, vital signs, and electrocardiograms to assess safety and effectiveness. Participants will be involved in regular visits and assessments throughout the treatment and follow-up periods, lasting up to about 72 weeks in total.

Researchers are evaluating ITI-1284, a study drug, for treating psychosis in patients with Alzheimers disease. This multicenter, randomized, double-blind study compares ITI-1284 with a placebo to assess its efficacy, safety, and tolerability in this population. The study includes patients diagnosed with Alzheimers disease and associated psychosis, focusing on improving psychosis symptoms as measured by specific scales. Participants will be randomly assigned to receive either ITI-1284 or a placebo during a 6-week double-blind treatment period. ITI-1284 is given as a 10 mg or 20 mg tablet taken once daily under the tongue. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. After treatment, a safety follow-up visit occurs approximately 30 days later to monitor any effects. During the study, participants will undergo various assessments including psychosis rating scales BEHAVE-AD psychosis subscale and CGI-S score at baseline and Week 6. Researchers will monitor safety, tolerability, and adherence throughout treatment and follow-up. The total participation time includes screening, treatment, and the 30-day safety follow-up period, allowing detailed evaluation of the study drugs impact and participant well-being.

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 23 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.