Safety of SPD465 in Treating Adults With ADHD. - Full Text View

Purpose

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 III

MedlinePlus related topics:

Attention Deficit Hyperactivity Disorder

ChemIDplus related topics:

Sodium chloride Dextroamphetamine Dextroamphetamine sulfate Amphetamine Amphetamine sulfate Amphetamine aspartate Dextroamphetamine saccharate Aspartic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase III, Multi-Center, 12-Month, Open-Label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

Further study details as provided by Shire Pharmaceutical Development:

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

Eligibility

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

Criteria

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

No Contacts or Locations Provided

More Information

Study ID Numbers:	SPD465-304
First Received:	September 7, 2005
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00152035
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms

Dopamine

Attention Deficit Disorder with Hyperactivity

Mental Disorders

Dextroamphetamine

Mental Disorders Diagnosed in Childhood

Neurologic Manifestations

Attention Deficit and Disruptive Behavior Disorders

Hyperkinesis

Amphetamine

N-Methylaspartate

Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Uptake Inhibitors

Sympathomimetics

Nervous System Diseases

Physiological Effects of Drugs

Central Nervous System Stimulants

Pharmacologic Actions

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00152035