blind, placebo-controlled study conducted to eva luate change in executive function behaviours, key quality of life outcomes, and ADHD symptoms in adults with ADHD and a clinically significant impairment in executive function. The study enrolled adults aged 18 to 55 years (n=161) who met DSM-IV criteria for ADHD as assessed by a total score of ≥65 on the Behaviour Rating Inventory of Executive Function – Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score by subject-report and a score of ≥28 using the Adult ADHD-RS with prompts at the Baseline visit. At Week 10 the mean subject-reported BRIEF-A GEC T-score was 68.3 for the placebo group and 57.2 for the SPD489 group, representing LS mean changes from baseline of -11.1 and -22.3, respectively. The effect size was 0.74 in favour of the SPD489 group. The difference in LS mean change from baseline to week 10 (-11.2) was significantly better in the Elvanse Adult group compared with placebo (p<0.0001). Secondary efficacy measures of Adult ADHD Impact Module (AIM-A), ADHD-RS with adult prompts, CGI-I and the ADHD Index T- score of the Conners' Adult ADHD Rating Scale – Observer: Short Version (CAARS-O:S) were all significantly better in the Elvanse Adult group compared with placebo.
Study 3 was a multi-centre, randomised, double-blind, placebo-controlled, crossover study. This study of Elvanse Adult was designed to simulate a workplace environment and enrolled 142 adults. Following a 4-week open-label, dose optimisation phase with Elvanse Adult (30, 50, or 70 mg/day in the morning), subjects were randomised to one of two treatment sequences: 1) Elvanse Adult (optimised dose) followed by placebo, each for one week, or 2) placebo followed by Elvanse Adult each for one week. Efficacy assessments occurred at the end of each week, using the Permanent Product Measure of Performance (PERMP). The PERMP is a skill- adjusted maths test that measures attention in ADHD. Elvanse Adult treatment, compared to placebo, resulted in a statistically significant improvement in attention across all post-dose time points, as measured by average PERMP total scores over the course of one assessment day, as well as at each time point measured. The PERMP assessments were administered at pre-dose (-0.5 hours) and at 2, 4, 8, 10, 12, and 14 hours post-dose.
Study 4 examined maintenance of efficacy. This study was a double-blind, placebo- controlled, randomised withdrawal design study was conducted in adults aged 18 to 55 (n=123) who met DSM-IV criteria for ADHD. At study entry, subjects must have had documentation of treatment with Elvanse Adult for a minimum of 6 months and had to demonstrate treatment response as defined by CGI-S ≤3 and Total Score on the ADHD-RS with adult prompts <22. ADHD-RS with adult prompts Total Score is a measure of core symptoms of ADHD. Subjects that maintained treatment response at week 3 of open label treatment phase (n=116) were eligible to enter the double-blind randomised withdrawal phase, and received their entry dose of Elvanse Adult (n=56) or placebo (n=60). Maintenance of efficacy for subjects treated with Elvanse Adult was demonstrated by the significantly lower proportion of treatment failure (<9%) compared to subjects receiving placebo (75%) in the double-blind randomized withdrawal phase. Treatment failure was defined as a ≥50% increase (worsening) in the ADHD-RS with adult prompts Total Score and ≥2-point increase in the CGI-S score compared to scores at entry into the doub |
