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.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00151996
First received: September 7, 2005
Last updated: November 25, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride)
Drug: Amphetamine + SPD503
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Improvement on Parent Global Assessment (PGA) Scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: August 2004
Study Completion Date: May 2006
Arms Assigned Interventions
Experimental: Methylphenidate + SPD503 Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride)
Experimental: Amphetamine + SPD503 Drug: Amphetamine + SPD503

  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
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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00151996     History of Changes
Other Study ID Numbers: SPD503-205
Study First Received: September 7, 2005
Results First Received: September 10, 2009
Last Updated: November 25, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amphetamine
Methylphenidate
Central Nervous System Stimulants
Guanfacine
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists

ClinicalTrials.gov processed this record on August 28, 2014