ML-007C-MA-222 is a 52-week, flexible-dose, open-label extension study designed to evaluate the long-term safety, tolerability, and effectiveness of ML007C-MA in participants with ADP who have completed the antecedent study (ie, Study ML-007C-MA-221).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
210
ML-007C-MA dosed as 105/1.5 mg BID or 210/3 mg BID
Clinical Site
Anaheim, California, United States
Clinical Site
Doral, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
To assess the safety and tolerability of long-term ML-007C-MA administration in participants with hallucinations and delusions associated with AD
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
Time frame: From initial dose through end of treatment (up to 52 weeks)
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Clinical Site
Miami Gardens, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
Pernik, Pernik, Bulgaria
Clinical Site
Toulouse, France