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项与 MLD-10(Pharmalyte Solutions LLC) 相关的临床试验A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of MLD10 in the Prevention of Migraine Headache in Adults
This is a double-blind, placebo-controlled, randomized, multi-center study. Subjects agreeing to participate in the study and meet the entry criteria assessed at the screening visit, will begin a 28 day baseline period to confirm their diagnosis, as well as establish baseline migraine characteristics. During this baseline period, subjects will continue treating their migraines as usual, simply recording the information in a daily headache diary. Subjects who, after completing the baseline, continue to meet entrance criteria will be eligible to enter into the treatment phase and be randomized according to the Clinvest generated randomization schedule. Approximately 142 subjects (71 subjects per arm) will be randomized and enter the treatment phase receiving MLD10 or placebo in a 1:1 design at 6 United States sites. Diary assessments will collect study medication adherence, pain severity, headache symptoms, acute medication usage, and unusual symptoms. Serum samples will be collected and analyzed for ionized magnesium, electrolytes, and creatinine.
100 项与 MLD-10(Pharmalyte Solutions LLC) 相关的临床结果
100 项与 MLD-10(Pharmalyte Solutions LLC) 相关的转化医学
100 项与 MLD-10(Pharmalyte Solutions LLC) 相关的专利(医药)
100 项与 MLD-10(Pharmalyte Solutions LLC) 相关的药物交易