The purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Vince and Associates Clinical Research
Kansas City, Kansas, United States
ADHD-RS
The absolute and change from baseline in ADHD-RS scores, and percentage change from baseline in ADHD-RS score will be summarized appropriately
Time frame: 5 weeks
PERM-P
The average of the on-treatment total post-dose PERM-P scores for each treatment assessment day during the randomized treatment period will be calculated for each individual.
Time frame: 5 weeks
Clinical Global Impression (CGI)
The CGI scores will be summarised using frequency counts and percentages.
Time frame: 5 weeks
Safety and Tolerability
Parameters for evaluation of safety and tolerability: Adverse events, Clinical laboratory safety tests, Physical examination, Vital signs, 12-lead ECG, Telemetry, EGD findings, CSSRS, LSEQ
Time frame: 11 weeks
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