green Posted May 3, 2010 Report Share Posted May 3, 2010 Chelsea Theraputics is once again recruiting for a study on the use of Droxidopa to treat Neurogenic Orthostatic Hypotension. They will continue to recruit for the next few months. Anyone who thought about signing up but missed the enrollment window has another chance.The previous study failed to demonstrate that Droxidopa improved dizziness in people suffering from Neurogenic Orthostatic Hypotension. This imperiled Chelsea's application for FDA approval, so they appealed for permission to do a new study. In their appeal, Chelsea argued that the symptoms of orthostatic hypotension encompass more than just dizzyness. The FDA agreed and now they're going to measure whether Droxidopa improves a wider range of symptoms.Do other people out there agree with me that this seems fair? Hypotension can make a person feel lousy without necessarily making them dizzy, and, the degree of dizzyness a hypotensive experiences does not always correlate with their fatigue or brain fog? Or am I thinking wishfully because I want Droxidopa to be an effective treatment for autonomic disorders?I got all this information from Chelsea's website. Quote Link to comment Share on other sites More sharing options...
ramakentesh Posted May 3, 2010 Report Share Posted May 3, 2010 They are repeating the trial because in theory it should work in any postural hypotension where sympathetic underactivity is the underlying problem.It has been trialled unofficially in POTS and the results were not encouraging - despite some doctors touting it as the next medication on the horizon... Quote Link to comment Share on other sites More sharing options...
green Posted May 5, 2010 Author Report Share Posted May 5, 2010 They are repeating the trial because in theory it should work in any postural hypotension where sympathetic underactivity is the underlying problem.That is very interesting to hear. Do you remember where you came across that information? I read the company's report on why they were doing a retrial, and all they said was that the measurement of dizzyness was too narrow and they felt like a new study with a broader measure and additional test subjects would have more power and hence less of a chance of a type II statistical error. >It has been trialled unofficially in POTS and the results were not encouraging - despite some doctors touting it as the next > medication on the horizon...Do you remember where and by whom it was trialed? Quote Link to comment Share on other sites More sharing options...
ramakentesh Posted May 6, 2010 Report Share Posted May 6, 2010 Yeah it would be unusual for them to say otherwise... Most of the droxydopa studies were successful. it will work, but not maybe for POTS. Pm me for the details. Quote Link to comment Share on other sites More sharing options...
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