Dearborn Heights

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.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating treatments for women with nonatypical endometrial hyperplasia (NAEH), a condition where the lining of the uterus becomes too thick but is not cancerous. This condition, often caused by hormone imbalances, can lead to abnormal vaginal bleeding or irregular periods and may progress to cancer if untreated. Currently, no approved treatments exist, so this study aims to find better options. The main goal is to see if treatment with Mirena or oral medroxyprogesterone acetate (MPA) can restore the uterine lining to normal and be safe for participants. Participants will be randomly assigned in a 2:1 ratio to receive either Mirena, a device inserted into the uterus that releases progesterone, or daily oral MPA tablets for six months. Mirena is inserted at the start of treatment and removed after six months or earlier if the participant stops the study. Those taking oral MPA will take a 10 mg tablet once daily during the treatment period. Treatment lasts for six months, followed by a three-month observation without treatment. Participants will be involved for about 10 months, including up to five clinic visits: one before treatment starts, three during treatment spaced three months apart, and one after treatment ends. During visits, doctors will monitor health through blood and urine tests, vaginal ultrasound, hysteroscopy (a minor procedure to view the womb and collect tissue samples), and questions about symptoms and any medical issues. The study tracks the proportion of participants whose uterine lining returns to normal at six months, as well as monitoring for recurrence, progression, and any side effects.

Researchers are evaluating the safety, tolerability, and effectiveness of 600 mg boric acid vaginal inserts for treating vulvovaginal candidiasis (VVC). This Phase 3 clinical trial involves female patients who have acute symptomatic VVC and aims to compare two different dosing durations of boric acid inserts to a placebo. The study is designed as a randomized, placebo-controlled, double-blinded trial to provide clear information on treatment outcomes. Participants will self-administer vaginal inserts once daily for 14 days. There are three groups: one receiving boric acid inserts for the full 14 days, another receiving boric acid inserts for 7 days followed by placebo inserts for 7 days, and a third group receiving placebo inserts for 14 days. During treatment, patients will use an electronic diary to record symptoms, study drug use, sexual activity, menstrual bleeding, and other relevant information. The study includes 4 in-person visits and one phone follow-up over a total participation period of 28 days. Throughout the study, clinical, mycological, and overall outcomes will be assessed at Days 15 and 28. If symptoms persist, additional microbiologic tests will be performed. Participants will undergo evaluations including pelvic exams and laboratory tests, and may receive rescue treatment if necessary. The research team will monitor for the absence of VVC signs and symptoms as the primary outcome, alongside several secondary measures of clinical and mycological cure. Safety and adherence will be closely followed during this 28-day study period.

Researchers are evaluating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 with moderate to severe acne. This first-in-human Phase I/II trial aims to find the best vaccine dose and regimen by testing up to three injections at four different dose levels. Acne is a common inflammatory skin condition affecting millions worldwide, with current treatments largely unchanged for decades and no cure available. The study includes a Core Study and an optional Long-Term Extension. The Core Study has two main parts: cohorts receiving two injections and cohorts receiving three injections of the vaccine or placebo. Participants in certain cohorts will have an additional 30-month follow-up after the Core Study, while others may join a separate long-term extension study. The vaccine and placebo are given by intramuscular injection, and dose levels vary across groups. During the study, participants will have medical evaluations including blood tests and skin assessments. Researchers will track side effects shortly after each injection and over several months, as well as changes in acne lesions and immune responses. The study will measure both safety and how well the vaccine stimulates the immune system. Follow-up may continue for up to 40 months to monitor long-term effects and adverse events.