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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Phase 3 Study of Rimegepant for Intermittent Prevention of Menstrual Migraine in Women Aged 18 to 45
Researchers are evaluating the use of rimegepant for intermittent prevention of menstrual migraine in women aged 18 to 45 who experience migraine attacks related to their menstrual cycle. This Phase 3, double-blind, randomized study compares rimegepant with placebo to assess its efficacy and safety during the peri-menstrual period. The study focuses on migraine frequency and severity in women with a history of menstrual migraine and regular menstrual cycles. Participants receive either rimegepant 75 mg orally disintegrating tablets for 7 days during each peri-menstrual period or a matching placebo, along with standard care for acute migraine treatment as needed. The study treatment cycles are repeated over 5 menstrual cycles in the double-blind treatment phase. The study also includes an acute treatment dosing option with rimegepant as needed. During the study, participants will be monitored for changes in the number of migraine and headache days, use of migraine medications, and functional disability related to migraine. Cognitive function is also assessed. Researchers will conduct evaluations over 5 months, covering 5 menstrual cycles, and measure outcomes related to migraine frequency and severity during the peri-menstrual period. Safety and tolerability will be closely monitored throughout the study.
Actively Recruiting
The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.
Actively Recruiting
Researchers are investigating the use of head down tilt at -10 to -15 HDT15 as a possible therapy to improve collateral blood flow in adults with acute ischemic stroke caused by a blockage in the middle cerebral artery MCA. This multicenter, randomized, controlled, open-label trial with blinded outcome assessment aims to compare HDT15 positioning with the usual positioning 0 to 30 before mechanical thrombectomy, a procedure to remove the blockage. The study seeks to determine if HDT15 can enhance collateral circulation, extend the survival of brain tissue at risk, and improve outcomes from thrombectomy. The intervention group will have their head tilted downward by 10 to 15 starting in the Emergency Room and maintained during transfer to and throughout the mechanical thrombectomy procedure, using specialized equipment to ensure precise angles. The control group will receive standard care with usual positioning between 0 to 30. The HDT15 therapy is expected to last approximately 30 to 90 minutes, covering the critical period before and during thrombectomy. Participants will be closely monitored during the study for neurological changes, blood pressure, oxygen levels, and any side effects such as vomiting or pneumonia. Imaging assessments will be performed during thrombectomy to evaluate collateral blood flow. Functional outcomes will be measured up to three months after treatment. The study includes safety monitoring to track any complications and ensure patient well-being throughout the trial, which runs through the end of 2026.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate the reduction of emotional burden experienced by caregivers of migraine patients who also have depressive symptoms. The study focuses on assessing caregivers stress levels using the Relative Stress Scale RSS over six months following the initial injection of fremanezumab. It also explores the impact on mutual support between patients and caregivers, known as couple reciprocity. Participants include adult migraine patients diagnosed according to the International Classification of Headaches ICHD-3 and their informal caregivers who live in the same household. Patients will receive fremanezumab via subcutaneous injections, either 225 mg monthly or 675 mg quarterly, as part of their migraine prevention therapy. The study observes these treatments in a real-life setting without experimental manipulation. Throughout the six-month study, caregivers and patients will complete assessments measuring stress, reciprocity, depression, anxiety, and disability. Researchers will track changes from baseline to six months after starting fremanezumab therapy. The study involves diary compliance, written consent, and continuous monitoring of both patients and caregivers to understand how treatment affects their emotional well-being and relationship dynamics.
Actively Recruiting
Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.
Actively Recruiting
Researchers are evaluating the effects of a remotely delivered exercise program on brain functional connectivity and physical fitness in patients with small vessel disease SVD-related ischemic stroke. This prospective, randomized, multicenter trial will include patients aged 60 and older who have a history of lacunar stroke, minimal disability, and low physical activity levels. The study aims to understand how exercise may influence brain function and physical health in this population. Participants will be randomly assigned to one of two groups a 24-week telecoached exercise intervention or usual care. The exercise program consists of multicomponent physical exercises delivered remotely twice a week. After the initial 24 weeks, the control group will also receive the exercise intervention, allowing the assessment of immediate and lasting effects. Assessments occur at baseline, 12 weeks, 24 weeks, and 48 weeks. During the study, participants will undergo evaluations including brain connectivity measured by high-density EEG and physical fitness tests such as the Senior Fitness Test. Researchers will also monitor physical activity levels, body measurements, blood pressure, and heart rate. The trial includes adherence support through telecoaching and aims to gather comprehensive data on both neurophysiological and clinical outcomes over the study period.