Safety and Efficacy of SPD465 in Adults With ADHD

Study Overview
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Brief Summary
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The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.

Official Title
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A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of ADHD using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met) Baseline ADHD-RS-IV score =>24 IQ score of => 80 (using Kaufman Brief Intelligence Test) Exclusion Criteria: BMI < 18.5 or > 30 kg/m2 Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder History of uncontrolled hypertension or currently hypertensive Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine) Female subject is pregnant or lactating, less than 3 months post partum

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

| Intervention/Treatment |
| --- |
|Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERMP (Permanent Product Measure of Performance) |  | 0.5 hours pre-dosing | 
| PERMP (Permanent Product Measure of Performance) |  | 2 hours post-dosing | 
| PERMP (Permanent Product Measure of Performance) |  | 4 hours post-dosing | 
| PERMP (Permanent Product Measure of Performance) |  | 8 hours post-dosing | 
| PERMP (Permanent Product Measure of Performance) |  | 12 hours post-dosing | 
| PERMP (Permanent Product Measure of Performance) |  | 14 hours post-dosing | 
| PERMP (Permanent Product Measure of Performance) |  | 16 hours post-dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Segment Rating System (ADHD-RS[TSRS]) |  | 5½, 11, and 16½ hours post-dosing | 
| Subject self report (ADHD-SRS) of ADHD |  | approximately 5½, 11, and 16½ hours post-dosing | 
| Treatment emergent adverse events |  | Throughout the study period of approximately 3.25 months. | 
| Modified Pittsburgh Sleep Quality Index (PSQI) |  | Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit |