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

Attention-Deficit/Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928148
• Other study ID #: SPD465-201
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2004
• Est. completion date: November 20, 2004

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 20, 2004
• Est. primary completion date: November 20, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• SPD465
50 or 75 mg once daily for 7 days
• Immediate Release Amphetamine Salt
25 mg once daily for 7 days
• Placebo
Once daily for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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