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

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ClinicalTrials.gov Identifier: NCT00151996
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : November 26, 2009
Last Update Posted : December 1, 2009
Sponsor:
Information provided by:
Shire

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

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride) Drug: Amphetamine + SPD503 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : August 2004
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate + SPD503 Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride)
Experimental: Amphetamine + SPD503 Drug: Amphetamine + SPD503



Primary Outcome Measures :
  1. Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures :
  1. Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: 6 weeks ]
  2. Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ]
  3. Number of Participants With Improvement on Parent Global Assessment (PGA) Scores [ Time Frame: 6 weeks ]
  4. Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks [ Time Frame: Baseline and 6 weeks ]


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00151996     History of Changes
Other Study ID Numbers: SPD503-205
First Posted: September 9, 2005    Key Record Dates
Results First Posted: November 26, 2009
Last Update Posted: December 1, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Amphetamine
Guanfacine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists