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

NCT00928148 | Completed Phase 2

• 1 other identifier: SPD465-201
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

SPD465 (50 or 75 mg)

EXPERIMENTAL

Drug: SPD465

Immediate Release Amphetamine salt (25 mg)

ACTIVE COMPARATOR

Drug: Immediate Release Amphetamine Salt

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SPD465 DRUG

50 or 75 mg once daily for 7 days

SPD465 (50 or 75 mg)

Immediate Release Amphetamine Salt DRUG

25 mg once daily for 7 days

Immediate Release Amphetamine salt (25 mg)

Placebo DRUG

Once daily for 7 days

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shire: lead

Related Publications (1)

• Wigal T, Brams M, Frick G, Yan B, Madhoo M. A randomized, double-blind study of SHP465 mixed amphetamine salts extended-release in adults with ADHD using a simulated adult workplace design. Postgrad Med. 2018 Jun;130(5):481-493. doi: 10.1080/00325481.2018.1481712. Epub 2018 Jun 18.

  PMID: 29809075 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 25, 2009
• Study Start: June 14, 2004
• Primary Completion: November 20, 2004
• Study Completion: November 20, 2004
• Last Updated: June 3, 2021

Record last verified: 2021-05