Clinical trial NCT00928148: The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo- and Active-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.


Eligibility criteria: Inclusion Criteria:

* Adult men and non-pregnant women between the ages of 18 and 55
* Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
* Baseline ADHD score of at least 24

Exclusion Criteria:

* Weight less than 100 pounds or greater than 250 pounds
* Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
* Pregnancy or breastfeeding
* History of seizures
* Positive urine drug screen

Primary outcomes:
measure: To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test
timeFrame: -0.5, 2, 4, 8, 12, 14 and 18 hours post-dose
Secondary outcomes:
measure: To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the ADHD-rating scale (ADHD-RS)
timeFrame: 5, 10 and 15 hours post-dose
measure: To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) scale
timeFrame: 5, 10, and 15 hours post-dose
measure: To assess the impact of SPD465 compared with placebo and immediate release amphetamine on sleep as measured by the modified Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 21 days
measure: To evaluate the safety of SPD465 based on occurrence of treatment-emergent adverse events (TEAEs), blood pressure (BP), heart rate, electrocardiogram (ECG), and clinical laboratory findings
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Wigal T, Brams M, Frick G, Yan B, Madhoo M. A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design. Postgrad Med. 2018 Jun;130(5):481-493. doi: 10.1080/00325481.2018.1481712. Epub 2018 Jun 18.