Westborough

Researchers are evaluating Xeomin injections as a treatment to prevent chronic migraine in adults. This Phase 3 clinical trial compares the change in monthly migraine days between participants receiving Xeomin injections and those receiving placebo injections. The study involves participants diagnosed with chronic migraine who meet specific migraine frequency criteria. Participants will receive four treatments approximately 12 weeks apart, with injections administered into muscles in the head and neck at specific points. The trial includes a placebo-controlled period with two Xeomin dose groups and a placebo group, followed by an extension period where all participants may receive Xeomin. Treatments involve Xeomin or placebo injections prepared by reconstitution with saline. The study lasts about 52 to 55 weeks, including a 4 to 5 week screening period and multiple visits. Four visits are on-site for treatments, while others are remote via phone or video call. Researchers will monitor changes in migraine days and headache days, use of acute migraine medication, and any treatment-related side effects. The primary outcome is the change in monthly migraine days from before treatment to six months after the first injection.

Researchers are studying the use of Xeomin injections to prevent episodic migraine by comparing its effects to placebo injections. The study focuses on adults with episodic migraine who experience a limited number of migraine and headache days per month. The main goal is to measure changes in the number of monthly migraine days after treatment. Participants receive Xeomin or placebo injections in muscles of the head and neck at specific points. The study includes two Xeomin dose groups and a placebo group, with an extension period where placebo participants may receive Xeomin. Four treatments are given roughly 12 weeks apart during a trial lasting about 52 to 55 weeks. Participants attend 14 visits over the course of the study, with the first, last, and four treatment visits conducted in person. The remaining visits occur remotely via phone or video call. Researchers monitor migraine frequency changes, medication use, and any treatment-related adverse events. The primary outcome is the change in monthly migraine days after six months of treatment.

This research aims to evaluate the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraine by stopping the release of chemical messengers that cause migraine pain. Adults aged 18 to 80 with a history of migraine for at least one year will participate to help determine the best dose and overall safety profile of IPN10200. The study is a Phase II, randomized, double-blind, placebo-controlled trial sponsored by Ipsen. The study includes three main periods: an initial screening to determine eligibility, followed by Step 1 which tests two doses of IPN10200 in separate cohorts to assess safety over 36 weeks, and Step 2 where new participants are grouped by migraine type and randomly assigned to receive either Dose A, Dose B, or placebo. Treatments are given as injections into muscles of the head, face, and neck in a single treatment cycle for each dose or placebo group. Participants will be asked to complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety through adverse event reporting, laboratory tests, vital signs, facial examinations, ECG readings, and antibody levels. Efficacy will be assessed by changes in the number of monthly migraine and headache days. Safety and effectiveness data will be collected regularly until the final Week 36 visit.

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.