Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.

First Received: September 7, 2005 Last Updated: November 2, 2007 History of Changes

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00151996

Purpose

The purpose of this study is to assess the safety and tolerability of administering SPD503 with psychostimulants (amphetamine of methylphenidate) for treatment of ADHD in children and adolescents aged 6-17

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Guanfacine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase II, Open-Label Co-Administration Study of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Guanfacine Guanfacine hydrochloride

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Frequency of treatment emergent adverse events at 9 weeks

Secondary Outcome Measures:

Pediatric Daytime Sleepiness Scale
Pittsburgh Side Effect Rating Scale
ADHD-RS-IV scale
CGI-I and CGI-S scales

Estimated Enrollment:	70
Study Start Date:	August 2004
Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with a primary diagnosis of ADHD
Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild anxiety) with significant symptoms
History of seizure during the last 2 years
Subject has any specific cardiac condition or family history of significant cardiac condition
Subject is pregnant or lactating

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	SPD503-205
Study First Received:	September 7, 2005
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00151996 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Attention Deficit and Disruptive Behavior Disorders
Cardiovascular Agents
Antihypertensive Agents
Dyskinesias
Adrenergic Agonists

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Guanfacine
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Cardiovascular Agents
Antihypertensive Agents
Dyskinesias

Adrenergic Agonists
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Guanfacine
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 30, 2009