HNY all.
An update to the trial registration for the HEALEY Platform Trial Master Protocol has been posted: https://tinyurl.com/yc7yyxd8
As you will see from the link (which takes you to a comparison panel showing the changes made) key updates to the protocol include:
- Simplified outcome measures.
- Trial duration moves from 24 to 36 weeks.
- Eligibility criteria, most importantly time since onset shifting from 36 months to 24 months at the screening visit (so more newly diagnosed pax).
A further update to the master protocol will be required to include NUZ-001 once we have the green light from the FDA.
Cheers
Densy
Ann: Neurizon Files IND Application to Support HEALEY ALS Trial, page-94
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