This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
297
Change score from baseline of the ADHD-RS
Time frame: 4 weeks
Duration of therapeutic responses using the CPRS ADHD Index
Time frame: At treatment endpoint, separately for morning, afternoon and evening responses
Clinical global impression of severity(CGI-S) and improvement (CGI-I)
Time frame: Treatment endpoint
Treatment emergent AEs
Time frame: 4 weeks
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Placebo