The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo- and Active-Controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder

Conditions
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Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Drug: SPD465
* Drug: Immediate Release Amphetamine Salt
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPD465 (50 or 75 mg)<br> | Drug: SPD465<br>* 50 or 75 mg once daily for 7 days<br>|
| Active Comparator: Immediate Release Amphetamine salt (25 mg)<br> | Drug: Immediate Release Amphetamine Salt<br>* 25 mg once daily for 7 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Once daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | -0.5, 2, 4, 8, 12, 14 and 18 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 5, 10 and 15 hours post-dose | 
| 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 |  | 5, 10, and 15 hours post-dose | 
| 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) |  | 21 days | 
| 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 |  | 21 days |