Waxahachie

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 pharmacodynamic effect, safety, and tolerability of Povetacicept in adults with generalized myasthenia gravis gMG. This phase 2 study focuses on participants aged 18 to 80 years who have generalized muscle weakness and fall within the MGFA clinical classification II-IV. The study aims to better understand how Povetacicept affects immunoglobulin levels and the safety profile in this population. Participants will be randomly assigned to receive one of two doses of Povetacicept or a placebo via subcutaneous injection for the initial 12 weeks. Those who are eligible may continue treatment with Povetacicept for an additional 96 weeks in a long-term extension phase. This study uses a double-blind, placebo-controlled design to evaluate the treatment over a total period of up to 108 weeks. During the study, participants will undergo evaluations of immunoglobulin G levels at baseline and week 12. Safety and tolerability will be monitored throughout the entire treatment period by tracking adverse and serious adverse events. The study includes regular assessments to measure outcomes and monitor participant health, with the goal of completing by March 2029.

Researchers are evaluating the safety and effectiveness of atogepant, a medicine approved for preventing migraine in adults, in young participants aged 12 to 17 years who experience chronic migraine. The study aims to compare atogepant with a placebo, which looks like the medicine but contains no active drug. It focuses on monitoring side effects and changes in migraine frequency in this pediatric population. Participants will be randomly assigned to receive either atogepant or placebo tablets once daily for 12 weeks in a double-blind design, meaning neither participants nor doctors know who receives which treatment. After the treatment period, participants will be followed for an additional 4 weeks to observe ongoing effects. The study plans to enroll about 420 adolescents across approximately 70 sites worldwide. During the study, participants will attend regular clinic visits where researchers will assess treatment effects through daily diaries, medical exams, blood tests, side effect monitoring, and questionnaires. The main outcomes include the number of participants experiencing adverse events and changes in the average monthly number of migraine days. Secondary measures cover headache days, medication use, quality of life, and migraine-related disability. Total participation lasts about 16 weeks.

Researchers are evaluating the safety and effectiveness of atogepant, a medication approved for adults with migraine, in children and teens aged 6 to 17 who have a history of episodic migraine. This Phase 3 study addresses the limited approved treatments available for pediatric migraine sufferers and aims to better understand atogepants impact on this younger population. Participants will be randomly assigned to one of six groups based on age and dosage. Children aged 6 to 11 will participate in a pharmacokinetic substudy to determine the appropriate dose before receiving either placebo, low-dose, or high-dose atogepant tablets once daily for 12 weeks. Teens aged 12 to 17 will be randomized to receive placebo, low-dose, or high-dose atogepant tablets daily for 12 weeks. After this period, participants may have a follow-up visit 4 weeks after their last dose or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular hospital or clinic visits for medical evaluations, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in the number of migraine and headache days, medication use, quality of life, and migraine-related disability. Safety will be monitored through adverse event reporting up to 16 weeks. The total study duration includes the 12-week treatment period with possible extension and follow-up assessments.

This research aims to evaluate the safety, tolerability, and effectiveness of the drug AP306 at fixed doses in adults with hyperphosphatemia who are undergoing maintenance hemodialysis. Hyperphosphatemia is a common complication in advanced chronic kidney disease and is linked to increased risks of cardiovascular problems, fractures, and death, especially in patients receiving dialysis. The study is a randomized, double-blind, placebo-controlled Phase 2b trial designed to assess these effects. Participants will receive AP306 orally at various fixed doses or placebo, administered daily for 8 weeks. The drug is given either twice or three times daily depending on the dose group, with doses ranging from 75 mg to 125 mg per administration. The study includes seven cohorts, six receiving different doses of AP306 and one receiving placebo, to compare safety and serum phosphate-lowering effects. Throughout the study, participants will be monitored with regular assessments including blood tests to measure serum phosphate levels and other safety parameters. Researchers will evaluate how well AP306 lowers phosphate levels over the 8-week treatment period. Participants adherence and tolerability to the medication will also be tracked. The trial will continue until March 2027, with data collection focused on treatment response and safety.

Researchers are evaluating the effects of elismetrep, an oral drug, compared with a placebo for the acute treatment of migraine in adults aged 18 to 75. This phase 3, double-blind, randomized study is conducted at multiple centers to assess the drugs safety, tolerability, and effectiveness in relieving migraine symptoms quickly. Participants receive either 10 mg or 20 mg of elismetrep or a placebo orally as part of the trial. The study uses a parallel design where participants are randomly assigned to one of these groups and neither the participants nor the researchers know which treatment is given until the study ends. During the trial, participants will be monitored for migraine pain relief and freedom from bothersome symptoms two hours after dosing, among other outcomes. Researchers will also assess pain relief at various time points, use of rescue medication, and safety by tracking any adverse events. Participants will complete questionnaires and use an eDiary app to record their experiences. The study is expected to last until February 2027.

Researchers are evaluating the safety, tolerability, pharmacodynamics, and effectiveness of multiple increasing doses of CNP-103 in people aged 12 to 35 who have been recently diagnosed with Stage 3 Type 1 Diabetes within the past 6 months. This Phase 1b2a first-in-human clinical trial aims to better understand how CNP-103 works in this population and to assess any immune safety concerns. Participants receive three intravenous doses of CNP-103 at varying amounts 100 mg, 300 mg, or 600 mg on Days 1, 8, and 90. The study includes multiple groups, including adolescent and adult cohorts, with dosing for an expansion group determined based on initial results. A placebo containing 0.9% sodium chloride is also used for comparison. The trial follows a parallel design with random assignment and double masking. The study lasts approximately 393 days and consists of a 28-day screening period, a 90-day treatment period, and a 275-day post-dose evaluation phase. Participants will be monitored for safety and immune safety throughout the entire year. Various assessments will be conducted during visits to track the effects and tolerability of the study drug, with regular follow-up to evaluate long-term outcomes.

Researchers are evaluating whether using ultrasound imaging inside blood vessels during minimally invasive treatment of leg arteries improves outcomes for patients with symptomatic peripheral artery disease PAD classified as Rutherford class 2-5. This prospective, multicenter randomized controlled trial in the U.S. aims to compare clinical results between ultrasound-guided and standard angiography-guided interventions. The study is led by the Baylor Research Institute and focuses on lower extremity arterial disease affecting several specific artery locations. Participants will receive one of two treatments either intravascular ultrasound IVUS guidance during their endovascular intervention or a standard angiographic-guided procedure without IVUS. The IVUS is used before and after procedures like atherectomy, balloon angioplasty, or stent placement to guide treatment. The trial follows participants through these treatments to assess outcomes over time. During the study, participants will be monitored for clinical success and functional improvements using questionnaires and classifications over 12 months, with primary patency assessed at 6 months. Researchers will also evaluate technical and procedural success during the initial procedure, survival without amputation, the need for repeat interventions, and cost effectiveness. The total study duration extends to July 2028, with ongoing assessments to measure the impact of ultrasound guidance on treatment results.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Migraine is a common neurological disorder that causes moderate to severe headache attacks, often with nausea, vomiting, and sensitivity to light and sound. This study is evaluating the safety and effectiveness of ubrogepant, a drug approved for adults, for the acute treatment of migraine in children and adolescents aged 6 to 17 years. The trial includes two participant groups a pharmacokinetic PK cohort for dose analysis in younger children and a main study cohort involving randomized treatment with different ubrogepant doses or placebo. Participants aged 6 to 11 years in the PK cohort will receive one of two doses of ubrogepant to determine dosing for the main study. In the main study, children aged 6 to 11 and adolescents aged 12 to 17 will be randomly assigned to low or high doses of ubrogepant or placebo, with a one in three chance of receiving placebo. For qualifying migraine attacks, participants will take oral tablets of the assigned study treatment, with the option of a second dose or rescue medication at least two hours later if headaches remain moderate or severe. Participants will be involved for up to six months and will attend regular hospital or clinic visits. Researchers will monitor treatment effects using medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome measured is the percentage of participants achieving pain freedom two hours after the initial dose. Safety, tolerability, and pharmacokinetic data will also be collected to understand ubrogepants effects in this younger population.