2. They wanted a double blinded study....i think that is premature, but probably needs to be done once we have figured out safety and best practice issues.
About six months ago I put you in contact with an Australian IR you previously knew or know of. He also applied for approval for a study here in Aus (and was rejected). Last time I saw him he explained the design of the study, and it sounded pretty interesting. Maybe you could email him again for clearer details.
The basics (from memory) were:
1. About 200 Patients (all MS)
2. Split into two groups (ie A & B each consisting of 100)
3. All patients would receive a venography, under a combination of 2 anaesthesia's. I don't remember the names of them, but one caused the patient to loose all track of time (so they had no idea how long they were in the operating theatre) and the second caused them to forget what happened during the procedure, with neither actually causing the patient to black-out, so they remained responsive to the person performing the procedure (ie hold your breath etc etc)
4. Half the patients would also receive treatment on this "first" venography, but no-one would be told if they did or didn't.
5. The raters were blinded to which patients were treated, and the dr's performing the venographies were to be kept away from the patient groups and raters.
6. Two months later, ALL patients would again undergo the venography, with the second group (not treated the first time) receiving treatment this second time. The patients that were treated in the first pass would be checked and treated for any restenosis.
The thing that sounded good regarding this study, was at worst, you would be treated in 2 months.
The dr's performing the venography / treatments are kept separate to the rest of the studies participants (ie patient, raters etc etc) so it attempts to approach the double blind criteria. They also had sneaky plans to push the placebo effect, but that would be hard to explain, clearly, not that the above does it all justice. I guess I simply liked the fact that worst case you would be treated in 2 months.
They also had plans to expect a % of people they didn't find CCSVI in, and the 200 (I think) number was based on achieving a certain confidence interval, assuming they didn't underestimate the number of people not found to have CCSVI.