Rochester Hills

Researchers are studying the effects of zelquistinel, a drug being evaluated for treating major depressive disorder (MDD) in adults aged 18 to 64 years. This Phase 2 clinical trial aims to find out if zelquistinel can reduce depression symptoms compared to a placebo and to assess its safety. Participants diagnosed with MDD and meeting specific severity criteria will be enrolled to better understand the drug's impact on depression scores and potential side effects. Participants will be randomly assigned to receive either zelquistinel or a placebo tablet once a week for six weeks. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug. The trial includes up to 28 days of screening, a 42-day treatment period with weekly clinic visits, and a 4-week follow-up phase. During visits, depression severity is measured using the Hamilton Depression Rating Scale-17 (HDRS-17). Throughout the study, participants will attend weekly clinic visits for depression assessments and monitoring of adverse events. Researchers will track changes in depression scores from baseline to six weeks to evaluate effectiveness. Safety evaluations and follow-up assessments continue for four weeks after treatment. The total participation time may last up to 98 days, including screening, treatment, and follow-up.

Researchers are evaluating the safety of OviTex PRS, a reinforced tissue matrix used in implant-based breast reconstruction surgeries, in women aged 18 to 75 years. This observational study looks at patients who previously received either permanent or resorbable OviTex PRS devices during immediate or two-stage unilateral or bilateral breast reconstructions, placed either above or below the chest muscle. The goal is to understand the safety profile of these devices and help guide future studies on their effectiveness. Participants in the study had undergone breast reconstruction surgery using OviTex PRS combined with implants, either permanent or resorbable types. The procedures included initial surgeries and any necessary exchange surgeries. The study collects data retrospectively and prospectively across multiple centers to assess outcomes related to the use of these devices. During the study, researchers track any significant adverse events within 24 months after implantation of the OviTex PRS device. Participants may be asked to return for follow-up visits, including photographic documentation. The study focuses on monitoring safety outcomes over two years, ensuring patients' recovery and device performance are carefully observed.

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

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 evaluating the effectiveness and safety of BHV-7000 in adults with refractory focal onset epilepsy, a condition where seizures originate in one area of the brain and do not respond well to current treatments. This Phase 2/3 clinical trial aims to determine whether BHV-7000 can reduce seizure frequency in this population. The study is divided into two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000, or a matching placebo, taken once daily. After completing Part A, participants move to Part B, where they are randomized to receive 75 mg of BHV-7000 or a matching placebo, also taken once daily. Both parts are randomized and double-blinded to ensure unbiased results. Participants will be monitored from Week 8 to Week 20 of each part for changes in average seizure frequency, serious adverse events, discontinuations due to side effects, and laboratory abnormalities. Researchers will track seizure diaries and assess safety and tolerability throughout the study. The total duration includes both study parts with regular evaluations to measure the drug’s impact and participant safety.

Researchers are investigating the effects of subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adults with knee osteoarthritis (OA) pain. This Phase 3, randomized, double-blind, placebo-controlled study aims to evaluate changes in knee pain and function. The study will enroll approximately 466 participants who meet specific clinical and radiographic criteria for knee OA and have experienced pain despite prior treatments. Participants will be randomly assigned to receive either PPS at a dose of 2 mg/kg or placebo via subcutaneous injections twice weekly for 6 weeks. The study includes a 7-week screening period, followed by the 6-week treatment phase, and a 52-week follow-up period, totaling up to 64 weeks of participation. An interim analysis will be conducted after about half of the participants complete Day 112, with final analysis after all complete Day 404. Throughout the study, participants will attend visits twice weekly during treatment and every 4 to 6 weeks during follow-up. Researchers will assess knee pain using a daily pain rating scale and monitor changes from baseline up to Day 112. Safety and treatment effects will be evaluated through clinical exams, laboratory tests, and imaging as needed. Participants must adhere to stable non-pharmacologic treatments and limit use of certain medications during the trial.

Researchers are investigating the effect of Dyanavel XR on fatigue symptoms in adults diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). This phase 4 trial aims to determine whether Dyanavel XR can significantly reduce fatigue compared to a placebo, using the Fatigue Symptom Inventory as the main measurement tool. The study focuses on adults aged 18 to 65 who experience clinically significant fatigue along with ADHD symptoms. This 10-week, single-center, randomized, double-blind, placebo-controlled trial assigns participants to either a flexible dosing group receiving Dyanavel XR or a placebo group. Dosing begins at 5 mg each morning and can be adjusted over the first four weeks based on symptom evaluation and side effects. Participants return weekly and later bi-weekly for assessments, with the principal investigator available for dosage consultations during the initial four weeks. Participants will complete the Fatigue Symptom Inventory at multiple points including screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 to measure fatigue levels. Throughout the study, symptom evaluation, safety monitoring, and adherence to dosing schedules are conducted. The study includes an intent-to-treat approach and handles missing data with statistical methods. Overall, participant involvement spans approximately 10 weeks with regular visits for monitoring and assessment.

Researchers are evaluating ACP-204, a drug that blocks a specific serotonin receptor, in adults aged 55 to 95 with Alzheimer's Disease Psychosis (ADP). The study is designed as a master protocol with three independent, multicenter, randomized, double-blind, placebo-controlled trials. The trials include Phase 2 and Phase 3 studies to assess the drug's effectiveness and safety in treating psychotic symptoms associated with ADP. The research involves three substudies. Substudy 1 (Phase 2) tests two doses of ACP-204, 30 mg and 60 mg, against a placebo to evaluate dose response. Substudies 2A and 2B (both Phase 3) will independently confirm the effects of either both doses or a single dose from Part 1 compared to placebo. Each substudy includes a screening period of up to 49 days, a six-week double-blind treatment phase, and a 30-day safety follow-up for those not continuing into an open-label extension. Vital status follow-up is conducted for participants who end the study early. Participants will receive regular assessments, including evaluations of psychotic symptoms using the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales from baseline to Week 6. Other study involvement includes brain imaging scans and biomarker tests to confirm Alzheimer's disease diagnosis, cognitive testing, and monitoring of safety and vital status throughout the study periods. Stable living arrangements and support from a caregiver are required to complete all study visits.

This research collects data and biological samples from patients who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and clinical information to help future studies understand, predict, prevent, and treat serious immune-related side effects, rare infections, or rapid tumor growth after immunotherapy. Participants provide tissue and blood samples when they join the study and again one month later. Some patients may also provide stool samples if they have certain side effects like colitis. Researchers also review participants' medical records for up to one year to gather detailed health information related to their treatment and side effects. During the study, patients undergo sample collections and have their health records examined. The main outcome measured is the establishment of a national biorepository containing these samples and data, which will be used in future research over the course of one year. This study aims to support better understanding and management of immunotherapy side effects in cancer treatment.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.