Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety of SPD465 in Treating Adults With ADHD.

This study has been completed.
Information provided by:
Shire Identifier:
First received: September 7, 2005
Last updated: November 2, 2007
Last verified: November 2007

The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.

Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity.
Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Multi-Center, 12-Month, Open-Label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination.

Secondary Outcome Measures:
  • ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter.
  • Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET).
  • Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET.

Estimated Enrollment: 1040
Study Start Date: March 2005
Study Completion Date: May 2007

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
  • Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.

Exclusion Criteria:

  • Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
  • Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
  • History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
  • Females who are pregnant of lactating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided Identifier: NCT00152035     History of Changes
Other Study ID Numbers: SPD465-304
Study First Received: September 7, 2005
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on March 03, 2015