Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00150618
First received: September 6, 2005
Last updated: November 25, 2009
Last verified: November 2009
  Purpose

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: SPD503 (1 mg)
Drug: SPD503 (2 mg)
Drug: SPD503 (3 mg)
Drug: SPD503 (4 mg)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 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 Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Number of Participants With Improvement in Parent Global Assessment (PGA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 324
Study Start Date: April 2004
Study Completion Date: May 2006
Arms Assigned Interventions
Experimental: SPD503 (Guanfacine HCl) (1 mg) Drug: SPD503 (1 mg)
Other Name: Guanfacine hydrochloride
Experimental: SPD503 (2 mg) Drug: SPD503 (2 mg)
Experimental: SPD503 (3 mg) Drug: SPD503 (3 mg)
Experimental: SPD503 (4 mg) Drug: SPD503 (4 mg)
Placebo Comparator: Placebo Drug: Placebo

  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
  • Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
  • Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

  • Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
  • Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
  • Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
  • Subject is pregnant or lactating
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Guanfacine Extended release in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Trial. Sallee FR, McGough J, Wigal T, et al. J. Am. Acad. Child Adolesc. Psychiatry, 2009; 48(2):155-165.

ClinicalTrials.gov Identifier: NCT00150618     History of Changes
Other Study ID Numbers: SPD503-304
Study First Received: September 6, 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
Guanfacine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014