I would think it would be enough to initially open up veins to help alleviate fatigue. That way the end points would be shorter and the treatment would be available much sooner. Following treated patients over the long term to assess levels of progression and number of relapses could just be built into the study.
You clearly have experience with FDA trials and how they are conducted. I too have had some experience from the company side of clinical trials, and was having a similar thought.
How do we measure fatigue? Is a self-reported fatigue level adequate? It might work if you had an effective placebo so that false subjective improvement would cancel out , but how would you create an effective placebo when the treatrment is an angioplasty or stent?
This is not a cynical nay-saying comment...I really am curious if you can think of something. Since remissions and spontaneous improvements are a typical part of MS and since brain problems are particularly subjective, this strikes me as a difficult problem.
I have PPMS with no relapses and remissions, so there isn't objective to measure. As a result, all the tests and research has been devoted to drugs to reduce relapses since there is something to count and create data to show the FDA, even though the evidence shows that those drugs do not slow progresson very much if at all. Creating measurable data, especially in a resonable time frame, is something I am too painfully aware of.