The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Information source: Shire
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention-Deficit/Hyperactivity Disorder
Intervention: SPD465 (Drug); Immediate Release Amphetamine Salt (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Shire
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: 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)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 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) 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
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: March 2004
Last updated: June 23, 2009
|