Anavex Life Sciences Corp (AVXL)

[Doc328]

LAST UPDATE: 13/09/2018
Authorization
03/07/2018
Start of Test
09/09/2018
First patient inclusion
09/09/2018

This seems to be good news. I couldn't find the info above but if true it looks like the first patient had a screening visit earlier this week so should soon be dosed. The Spanish registry info I saw did say start of test 09/09/18 but first patient inclusion still says 'not provided'. If they pass the screen only 119 to go. At the Spanish Registry site 6 of 20 sites were 'green' for active. This usually means they have regulatory and ethical board approval to begin to screen/enroll. I wonder how many sited are active in AU for the AD trial

From another site

F.4 Planned number of subjects to be included
F.4.1 In the member state 120
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition) none

So, it looks like there is no open label extension planned for the Spanish study. On one hand, this saves a lot of money. On the other, this might slow enrollment as patients will only be on drug a couple months and then have to stop, so caregivers may not feel the effort is worth it.


From the WHO site they list whether a site has prospective registration (and the PD site does). Did someone blunder by not registering the AU AD trial on time? This is still strange that the trial is not listed