Westborough

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing chronic migraine. This Phase 3, randomized, double-blind, placebo-controlled trial includes an extension period and aims to measure changes in the number of monthly migraine days. Participants have chronic migraine and meet specific criteria related to headache frequency and migraine history. Participants receive Xeomin or placebo injections into muscles of the head and neck at pericranial and cervical points. The study includes two Xeomin dose groups and a placebo group during the controlled period, with all groups receiving Xeomin in the extension phase. Four treatments are given approximately 12 weeks apart over a total study duration of 52 to 55 weeks. Participants take part in 14 visits over the study period, with the first, last, and four treatment visits conducted in person and the remaining eight visits by phone or video call. Researchers collect headache and migraine data from diaries and assess changes in monthly migraine days as the primary outcome. Safety is monitored by tracking treatment-related adverse events throughout the trial.

Researchers are evaluating the use of Xeomin injections to prevent episodic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections in the muscles of the head and neck to measure changes in the number of monthly migraine days. Participants have episodic migraine with or without aura, and the study aims to assess the efficacy and safety of different Xeomin doses over time. Participants receive a series of four Xeomin or placebo injections spaced about 12 weeks apart. The study includes two experimental groups receiving different Xeomin doses and a placebo group, followed by an extension period where some participants receive Xeomin. Injections are given at specific points around the head and neck. The trial lasts approximately 52 to 55 weeks, starting with a 4 to 5 week screening period. Participants attend about 14 visits, including the first and last visits and four treatment visits conducted on-site, with other visits done remotely by phone or video call. Researchers monitor changes in monthly migraine days, headache days, and medication use, as well as any treatment-related side effects throughout the study.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.

This research aims to collect pregnancy outcome information from women who have undergone non-invasive pregnancy testing NIPT to check the genetic status of their fetus. The study evaluates the performance of routine improvements to the NIPT assay and seeks to identify factors linked to negative pregnancy outcomes. This observational study focuses on pregnant women aged 18 and older who received testing through Sequenom or Integrated Genetics. Participants in this study have already undergone NIPT as part of their routine care. Researchers will review the testing results and pregnancy outcomes without providing any additional treatments or interventions. The study uses data collected from the non-invasive testing device and gathers information about pregnancy progress and outcomes to analyze test effectiveness and related characteristics. During the study, researchers will collect and analyze data about pregnancy outcomes up to nine months after testing. No extra procedures or visits are required beyond standard care. The main goal is to assess how well the NIPT performs clinically and to understand factors that may influence pregnancy results. Participation involves sharing pregnancy outcome information for research purposes only.

Researchers are conducting an observational study to learn about the experiences of people living with Myasthenia Gravis MG in the United States. The study aims to understand how and when MG is diagnosed, the common symptoms, treatments used, and the impact of MG on daily activities, employment, and quality of life. It also explores experiences related to disease flare-ups, hospitalizations, and access to healthcare. Participants with MG will join a patient-reported registry where they provide information via surveys. After enrolling through an initial survey, participants are invited to complete update surveys twice a year to share ongoing information about their condition and experiences. Throughout the study, participants will answer surveys that include questions about their diagnosis, symptoms, treatments, and life impacts. The main measurement is confirming the diagnosis of MG at enrollment. The study is led by the Myasthenia Gravis Foundation of America and follows participants over time to gather detailed patient-reported data about living with MG.