Rochester Hills

Researchers are evaluating zelquistinel, a drug aimed at reducing symptoms of major depressive disorder in adults aged 18 to 64 years. This Phase 2 clinical trial compares the effects and safety of zelquistinel to a placebo in participants diagnosed with major depressive disorder. The study will focus on changes in depression severity and monitor any medical issues that arise during treatment. Participants will take one tablet of either zelquistinel or placebo once a week for six weeks. The trial includes a screening period of up to 28 days, followed by a 42-day treatment phase, and then a four-week follow-up period. During treatment, participants will visit the clinic weekly to receive their dose and have their depression symptoms assessed using the Hamilton Depression Rating Scale-17. Throughout the study, participants will have their depression severity regularly evaluated, along with monitoring for adverse events or side effects. The study lasts up to 98 days, including screening, treatment, and follow-up. Researchers will measure changes in depression scores from the beginning to the end of treatment and monitor overall safety during this time.

Researchers are evaluating the safety profile of OviTex PRS, a reinforced tissue matrix device, in patients who have previously undergone implant-based breast reconstruction. This observational study includes both retrospective and prospective data and focuses on women aged 18 to 75 years who received either pre-pectoral or sub-pectoral breast implants using OviTex PRS. The study aims to understand overall safety and device-specific safety to help guide future studies on effectiveness. The study involves patients who had immediate or two-stage unilateral or bilateral implant-based breast reconstruction using OviTex PRS devices, either permanent or resorbable. The reconstruction could have been performed in the sub-pectoral or pre-pectoral position. This multi-center study includes patients who have completed their initial and, if applicable, exchange surgeries. Some participants may also take part in a prospective portion that includes returning for in-person visits and photograph completion. Participants will be followed for safety outcomes up to 24 months after OviTex PRS implantation. Researchers will collect data on the occurrence of relevant adverse events, time to expander or implant exchange, intraoperative fill volumes and visits, and aesthetic assessments using the Telemark Breast Score and Rainbow Scale. Hospitalization length of stay at the time of procedure will also be recorded. The study monitors participant adherence and safety throughout this period, providing important insights into the devices use in breast reconstruction.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

This trial investigates orelabrutinib, a brain-penetrating BTK inhibitor, in patients with non-active Secondary Progressive Multiple Sclerosis SPMS. It is a phase 3, randomized, double-blind, multicenter study comparing the effects and safety of orelabrutinib against a placebo. The study will enroll about 990 participants worldwide, focusing on those with SPMS who have not had recent relapses. Participants will be randomly assigned in a 21 ratio to receive either oral orelabrutinib daily or a placebo. After a screening period of up to 4 weeks, the treatment period will last from approximately 24 to 60 months, with a minimum of 12 months treatment. Those who experience confirmed disability progression may enter a 2-year open-label phase receiving orelabrutinib. A 4-week safety follow-up will occur for those who discontinue treatment before study end or do not enter long-term safety monitoring. During the study, participants will have assessments including disability progression measured over 24 weeks, MRI scans, and various functional tests up to about 120 weeks. Researchers will monitor safety and tolerability throughout. Participants will have a final end-of-study visit within 4 weeks after study completion, with ongoing treatment or follow-up depending on eligibility for long-term safety studies.

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.

This trial studies the safety and tolerability of different doses of PCRX-201, an investigational injection, for adults aged 45 to 80 with painful osteoarthritis of the knee. It compares two doses of PCRX-201 to placebo over one year, assessing adverse events and exploring effects on knee pain and joint function. The study includes two parts using PCRX-201 manufactured by different processes, enrolling 135 participants with specific knee osteoarthritis grades. Participants receive a single knee injection of PCRX-201 or placebo after a steroid pretreatment with methylprednisolone acetate. The study randomly assigns subjects to dose groups stratified by knee osteoarthritis severity using X-rays and MRI or ultrasound for synovitis assessment. Part A enrolls 45 subjects Part B enrolls 90 subjects, contingent on drug availability. Both parts include careful screening and dosing procedures. Participants attend multiple clinic visits for pretreatment, injection, and follow-up assessments. Visits occur weekly, bi-weekly, and then monthly through Week 52, followed by 8 visits over the next four years. Researchers monitor adverse events, inflammation markers, antibody levels, and knee pain through questionnaires and laboratory tests. The total participation can last up to five years for long-term safety and effectiveness monitoring.

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.

Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium PPS compared with placebo in adults experiencing knee osteoarthritis OA pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.

Researchers are studying the impact of Dyanavel XR on fatigue in adults diagnosed with Attention DeficitHyperactivity Disorder ADHD. This clinical trial aims to determine if Dyanavel XR can reduce fatigue symptoms compared to a placebo. The study uses a randomized, double-blind, placebo-controlled design with flexible dosing over a 10-week period. Participants will be randomly assigned to receive either Dyanavel XR or a matching placebo, starting at 5 mg once daily in the morning. Dosage may be adjusted weekly or bi-weekly based on individual response and side effects, with the investigator available to guide dosing between Weeks 0 and 4. Tablets should be swallowed whole and can be taken with or without food. Throughout the study, participants will attend regular visits for symptom evaluation and side effect monitoring. Various assessments, including the Fatigue Symptom Inventory, Behavior Rating Inventory of Executive Functioning-Adult, ADHD Rating Scale, and other quality of life and sleep questionnaires, will be conducted at screening, baseline, and multiple weeks during treatment. Safety and efficacy will be closely monitored, and the study is expected to conclude by December 2026.

Researchers are evaluating ACP-204, a drug targeting serotonin receptor subtype 2A, in adults aged 55 to 95 years with psychosis related to Alzheimers disease. This master protocol includes three independent, randomized, double-blind, placebo-controlled studies aimed at assessing the drugs efficacy and dose response. Substudy 1 is a Phase 2 trial comparing two doses of ACP-204 30 mg and 60 mg to placebo, followed by two Phase 3 confirmatory studies Substudies 2A and 2B that will independently evaluate the doses or a selected dose against placebo. Participants will undergo a screening period lasting up to 49 days before starting a six-week double-blind treatment phase where they will receive daily doses of ACP-204 or placebo, taken once a day at about the same time with or without food. After treatment, there is a 30-day safety follow-up for those not entering an open-label extension, and vital status follow-up for those who end the study early. Each substudy is analyzed separately to assess the drugs impact. During the trial, participants are closely monitored with assessments including the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions SAPS-HD from baseline to week 6. Other evaluations include clinical global impression scales and safety monitoring. Participants must have a study partner or caregiver to assist with visits and adherence. The study is designed to track changes in psychosis symptoms and overall safety through the treatment and follow-up periods.