Williamsville

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the effectiveness and safety of Xeomin injections in preventing chronic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections given into muscles of the head and neck. Participants have chronic migraine diagnosed for at least 12 months and meet specific headache and migraine day criteria. The study aims to measure changes in monthly migraine days over time with Xeomin treatment. Participants will receive four treatments spaced about 12 weeks apart over a total study duration of 52 to 55 weeks. The treatments involve injections of either Xeomin or placebo solution prepared with sodium chloride. Visits occur approximately every 4 weeks, totaling 14 visits: the first, last, and four treatment visits are on-site, while the other eight visits are remote via phone or video call. During the study, participants will keep headache diaries to track migraine and headache days. Researchers will focus on the change in monthly migraine days from baseline to six months after the first injection. Safety and effectiveness are monitored throughout, with frequent assessments during both on-site and remote visits to ensure accurate tracking of migraine symptoms and any side effects.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing episodic migraine. This phase 3 clinical trial focuses on adults who experience episodic migraine, aiming to measure changes in the number of migraine days per month. Participants must have a diagnosis of episodic migraine for at least 12 months and meet specific headache frequency criteria. Participants will receive four treatments of either Xeomin or placebo injections into muscles of the head and neck, with treatments spaced about 12 weeks apart. The entire trial lasts approximately 52 to 55 weeks, beginning with a screening period of 4 to 5 weeks. There are about 14 visits in total, with the first, last, and four treatment visits conducted on-site, while the other visits are held remotely via phone or video. Throughout the study, participants will track their migraine days using a headache diary, and researchers will assess changes in monthly migraine frequency from baseline to six months after the first injection. Regular monitoring includes both in-person and remote assessments. The primary outcome focuses on the change in monthly migraine days between baseline and month six after treatment initiation.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are conducting a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b trial to evaluate the effectiveness, safety, and tolerability of IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite antithyroid drug treatment. The study focuses on participants aged 18 to 75 years who have this diagnosis and are still experiencing hyperthyroidism. Participants will receive either IMVT-1402 or a placebo for 26 weeks. The study includes two dosing regimens of IMVT-1402: Dose 1 administered for 26 weeks and Dose 2 also administered for 26 weeks. The placebo group will receive treatment for the same duration. The treatments are given as drugs, and the study is designed to keep both participants and researchers unaware of which treatment is assigned. During the study, researchers will monitor participants to see how many achieve normal thyroid function (euthyroid) and remain off antithyroid drugs by Week 26. Participants will be assessed regularly to evaluate safety, tolerability, and treatment effects. The involvement includes following the assigned treatment and attending scheduled visits for evaluations. The total participation time corresponds with the 26-week treatment period.

Researchers are evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.

Researchers are evaluating the effectiveness and safety of a new drug combination called Mezigdomide (CC-92480) with bortezomib and dexamethasone (MeziVd) compared to an existing combination of pomalidomide, bortezomib, and dexamethasone (PVd). This study focuses on adults with relapsed or refractory multiple myeloma (RRMM) who have previously received between one and three lines of therapy, including prior lenalidomide treatment. The trial is a Phase 3, randomized, multicenter, open-label study aiming to improve outcomes for this condition. Participants will be assigned to receive either the MeziVd or PVd treatment regimen, with specified doses of each drug given on certain days. The study involves two treatment groups: one receiving mezigdomide, bortezomib, and dexamethasone, and the other receiving pomalidomide, bortezomib, and dexamethasone. Both regimens follow precise dosing schedules as determined by the study protocol. During the study, participants will be monitored regularly for disease progression or death, with the primary outcome being progression-free survival over up to approximately five years from the date of randomization. Ongoing assessments will include evaluations of safety and effectiveness. The total participation time may vary, and researchers will closely follow participants to gather detailed information on treatment responses and adverse effects.

Researchers are evaluating the safety and effectiveness of the CEM-Cage used with the CEM-Plate for patients undergoing a 2-level anterior cervical discectomy and fusion (ACDF) to address neck pain and cervical spine conditions such as spondylosis and radiculopathy. This prospective, first-in-human, multi-center, non-randomized, single-arm study will enroll fifty patients aged 22 to 79 years who have symptomatic cervical degenerative disc disease at two contiguous levels. The study aims to assess both the fusion success and overall surgical success over a 24-month period. Participants will undergo the 2-level ACDF surgical procedure using the CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System. Following surgery, patients will be monitored through a screening period, the operation itself, and six post-operative visits at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. Imaging tests such as static lateral cervical x-rays at 4 weeks and flexion/extension and neutral lateral radiographs at subsequent visits will help assess implant positioning, fusion, and overall success. Quality of life scales and adverse events will be recorded at each visit. Throughout the study, participants will complete evaluations including imaging, clinical assessments, and quality of life questionnaires to monitor treatment outcomes and safety. Researchers will track fusion rates and surgical success, defined by implant performance, absence of serious adverse events, and no need for further surgery at the treated levels. The total participation lasts 24 months with regular follow-up visits to ensure thorough monitoring of patient progress and device performance.

Researchers are conducting a Phase 2 randomized, double-blinded, placebo-controlled adaptive platform trial to study treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This trial focuses on evaluating the safety, tolerability, and effectiveness of multiple potential drug treatments using a shared control group to compare interventions. One group in this trial is studying fluoxetine, a medication used to treat PTSD symptoms. Participants in the fluoxetine group will be randomly assigned to receive either fluoxetine or a placebo in a 5:3 ratio during a 12-week treatment period. Fluoxetine dosing starts at 10 mg daily for one week, then increases to 20 mg daily for two weeks, followed by 40 mg daily for two weeks, and then 60 mg daily for the remainder of the trial. Dose reductions are allowed once if needed for tolerability, but doses will not be increased after a reduction. The study includes a 30-day screening period before treatment and a 4-week safety follow-up after treatment. Participants will undergo evaluations including the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) to measure PTSD symptoms and the Columbia Suicide Severity Rating Scale (C-SSRS) to monitor suicidal thoughts or behaviors. These measures will be assessed at the end of the 12-week treatment or at early termination. Safety and tolerability will be closely monitored throughout the study. Total participation involves screening, treatment, and follow-up lasting approximately 16 weeks.

Researchers are conducting a Phase 2 adaptive platform trial to evaluate several potential drug treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This part of the trial focuses on studying daridorexant, assessing its safety and effectiveness compared to a placebo. The study design allows participants to be randomly assigned to different treatment groups, sharing a common placebo control for comparison. Participants who qualify under the Master Protocol undergo a 30-day screening period before being randomized into the daridorexant group or placebo group in a 5:3 ratio. Those receiving daridorexant take a 50 mg dose once daily, at least two hours after their last meal and within 30 minutes of going to bed. The treatment phase lasts 12 weeks, followed by a 4-week safety follow-up to monitor participants after treatment. Throughout the study, researchers measure changes in PTSD symptoms using the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) over 12 weeks. They also track any new or worsening suicidal thoughts or behaviors via the Columbia Suicide Severity Rating Scale (C-SSRS). The total study participation spans about 16 weeks, including screening, treatment, and safety monitoring periods.