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

Shire

Status and phase: Completed; Phase 2

Conditions: Attention-Deficit/Hyperactivity Disorder

Treatments: Drug: Immediate Release Amphetamine Salt; Drug: SPD465; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928148

SPD465-201

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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86 participants in 3 patient groups, including a placebo group

SPD465 (50 or 75 mg)

Experimental group

Treatment:

Drug: SPD465

Immediate Release Amphetamine salt (25 mg)

Active Comparator group

Treatment:

Drug: Immediate Release Amphetamine Salt

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo