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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and effectiveness of different doses of Corabotase also called IPN10200 for treating adults with upper limb spasticity. This study aims to understand how Corabotase affects the body and to determine which doses provide the best balance of safety and benefit. The trial involves adult participants aged 18 to 70 years who have spastic hemiparesis following stroke or traumatic brain injury and meet other specific health criteria. The study includes several groups receiving different doses of Corabotase, Dysport, or placebo as single injections into various upper limb muscles. Participants are assigned randomly to groups, with some in dose-escalation cohorts and others in fixed-dose groups. The injections are given once, and doses are carefully adjusted to assess safety and response. The trial uses a double-blind design, meaning neither participants nor researchers know who receives which treatment. Participants will be monitored over nine months with regular assessments including physical exams, vital signs, lab tests, and evaluations of muscle spasticity using the Modified Ashworth Scale. Researchers will track any side effects, antibody development, and changes in muscle tone and disability. Patient and physician impressions of treatment effects and pain levels will also be recorded. This long-term follow-up helps researchers understand how the treatments work and their safety over time.

Age: 18Years - 70YearsAll GendersPhase 1Phase 2
81 locations
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Actively Recruiting

Researchers are evaluating the effects of intravenous ferric carboxymaltose FCM compared with a placebo on death risk, heart failure events, NT-proBNP levels, and quality of life in patients who recently had an acute myocardial infarction AMI and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled clinical trial aims to assess these outcomes over a follow-up period ranging from 8 to 36 months. Participants are randomly assigned to receive either an intravenous 15-minute infusion of 1000 mg FCM diluted in saline or a placebo infusion of saline alone. The first dose is given on the day of randomization, with follow-up visits at 4, 8, 12, 18, 24, and 30 months to reassess participants and possibly repeat treatment if safety criteria are met. During the study, participants undergo evaluations including monitoring of death rates, heart failure events such as unplanned hospitalizations or emergency visits, changes in NT-proBNP concentration, and quality of life measured by the EQ-5D questionnaire. Safety and treatment effects are tracked throughout the follow-up period, which can last up to 36 months from the start of participation.

Age: 18Years - 90YearsAll GendersPhase 4
43 locations