The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
Placebo capsule taken once daily in the morning
SKAMP-DS scores across a treatment assessment day
Time frame: 1 week
SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day
Time frame: 1 week
Treatment emergent adverse events
Time frame: 1 week
PK profile and PK/PD relationship of NRP104
Time frame: After multiple doses
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