CX717 in the Treatment of Adult ADHD

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.

Inclusion criteria

• Subject had ADHD as established by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2
• Patients must have at least moderately severe ADHD symptoms:

• Subject had an ADHD-RS score of ≥22
• Subject had a CGI-S score of ≥4
• Subject was male
• Subject was 18 - 50 years old, inclusive
• Subject could read well enough to understand the informed consent form and other patient materials.

Exclusion criteria

• Subject had a DSM-IV diagnosis of ADHD not otherwise specified
• Subject had a current or lifetime history of bipolar disorder or any psychotic disorder as established by the Structured Clinical Interview for DSM-IV (SCID) (12)
• Subject had a current history of major depression, substance abuse or dependence, generalized anxiety disorder, obsessive compulsive disorder, panic disorder, or posttraumatic stress disorder as established by SCID
• Subject had a history of epilepsy, seizures, syncope, unexplained blackout spell(s), head trauma with loss of consciousness, or febrile seizures
• Subject had a currently active medical condition (other than ADHD) that in the opinion of the Investigator could interfere with the ability of subject to participate in the study
• Subject had a history of development delay in milestones
• By history, the subject had an IQ less than 80
• In the opinion of the Investigator, the subject had not derived significant therapeutic benefit from 2 or more appropriately dosed ADHD therapies
• Subject was currently taking medication specifically for treatment of ADHD symptoms (e.g., stimulants, atomoxetine, tricyclic antidepressants, or bupropion).

NOTE: subjects were off of stimulants for 2 weeks and off non-stimulant ADHD therapies for 4 weeks prior to the Period 1 Baseline Visit. Subject did not have evidence of a discontinuation or withdrawal reaction.

• Subject was currently taking an anti-depressant prescription medication (e.g., paroxetine, sertraline, venlafaxine, etc.) or St. John's Wort
• Subject was currently taking an anti-convulsant medication (e.g., phenytoin, carbamazepine, lamotrigine, valproic acid, etc.) or anti-psychotic medication
• Subject had a clinically relevant abnormality on Screening evaluation including physical examination, vital signs, ECG, or laboratory tests
• Subject was currently taking on a chronic basis any medication known to be primarily metabolized by a route other than the cytochrome P450 system
• Subject was unwilling to refrain from taking medications that may have interfered with the assessment of cognitive function. Examples included benzodiazepines, sedating anti-histamines, zolpidem, and zaleplon. Herbal preparations with effects on the central nervous system (e.g., St. John's Wort, melatonin) were prohibited. These medications and herbal preparations were also prohibited throughout the study.
• Subject was unwilling to refrain from taking more than 1 unit of alcohol within 24 hours of the clinic visits
• Subject had a Body Mass Index (BMI) of less than 18 or greater than 35. No waivers were allowed.
• Subject reported passive or active suicidal ideation or intent
• Subject was concurrently participating in another clinical research study or investigational drug trial or had participated within the past 1 month
• Subject was at high risk of non-compliance in the Investigator's opinion