A Randomized, Double-Blind, Two-Period Crossover Study to Assess the Efficacy And Safety of the Ampakine® Compound, CX717, versus Placebo in Adults with Attention-Deficit Hyperactivity Disorder
This study examined the clinical efficacy, tolerability and safety of CX717 in the treatment of adults with ADHD. The study was a double-blind, 2-period crossover study that compared 2 different doses of CX717 with placebo. Subjects were randomized to 1 of 4 different treatment sequences: placebo - low dose; low dose - placebo; placebo - high dose; or high dose - placebo. Each treatment period was 3 weeks with a 2-week washout between treatment periods. The doses chosen were 200 mg b.i.d. and 800 mg b.i.d.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
CX717 200 mg capsules BID
CX717 4 X 200 mg capsules BID
Placebo 200 mg or 800 mg capsules BID
ADHD-RS
Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) with Prompts The ADHD-RS is an 18-item scale that assesses the severity ADHD symptoms based on the symptom list in the DSM-IV. It is administered by a qualified health care professional. Each item is rated 0 - 3 (0=not present and 3=severe). Thus the scale has a range from 0 to 54.
Time frame: 3 Weeks
ADHD-RS subscales
Attention Deficit Hyperactivity Disorder Rating Subscales: hyperactivity consisting of items 1-4, 8-10, 17-18, and inattentiveness consisting of items 5-7 and 11-16.
Time frame: 3 Weeks
CGI-I
Clinical Global Impression of Improvement
Time frame: 3 Weeks
HAM-A
Hamilton Rating Scale of Anxiety
Time frame: 3 Weeks
HAM-D
Hamilton Rating Scale of Depression
Time frame: 3 Weeks
PSQI
Pittsburgh Sleep Quality Index
Time frame: 3 Weeks
ESS
Eppworth Sleepiness Scale
Time frame: 3 Weeks
ADHD-SRS
Attention Deficit Hyperactivity Disorder Self Rating Scale
Time frame: 3 Weeks
SCWT
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Stroop Color and Word Test
Time frame: 3 Weeks
CTMT
Comprehensive Trail Making Test
Time frame: 3 Weeks
CPT
Continuous Performance Task
Time frame: 3 Weeks
FBDS
Forward and Backward Digit Span
Time frame: 3 Weeks