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Language-based Learning Skills and Attention Deficit Hyperactivity Disorder (ADHD): Impact of Treatment With Sustained-release Guanfacine

This study is currently recruiting participants.
Verified July 2011 by Neurology Group of Bergen County, P.A.
Sponsor:
Collaborator:
Shire Development LLC
Information provided by:
Neurology Group of Bergen County, P.A.
ClinicalTrials.gov Identifier:
NCT01146002
First received: June 15, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

This study is investigating the effect of sustained-release guanfacine (Intuniv) on language-based learning skills in children age 6-12 who are diagnosed with attention deficit hyperactivity disorder (ADHD).


Condition Intervention Phase
Attention-deficit/Hyperactivity Disorder
 Drug: Guanfacine (sustained release)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Language-based Learning Skills and ADHD: Impact of Treatment With Sustained-release Guanfacine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Neurology Group of Bergen County, P.A.:

Primary Outcome Measures:
  • one-tailed t-test [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Improvement in Woodcock Johnson III score when taking sustained release guanfacine, compared to score on the same test prior to treatment.


Estimated Enrollment: 20
Study Start Date: June 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Guanfacine treated.
Single arm - all patients treated with study drug. Comparison is against pre-treatment performance.
 Drug: Guanfacine (sustained release)
Treated with study drug once screening and initial testing is completed (see protocol above)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Diagnosis of ADHD-inattentive or combined type.

Exclusion Criteria:

  • Intelligence (IQ) below 85 as determined by formal testing.
  • Identified or suspected genetic syndromes.
  • Autism or other pervasive developmental disorders.
  • Psychiatric disorders other than ADHD and oppositional defiant disorder.
  • Heart, liver or renal disease.
  • Cancer.
  • Epilepsy or non-febrile seizure history.
  • Cardiac arrhythmia, bradycardia, or syncope.
  • Any other condition considered to be potentially exacerbated or endangered by treatment with an alpha-2 agonist drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146002

Contacts
Contact: Peter L Heilbroner, MD, PhD 201-444-5612 ext 237 pheilbroner@neurobergen.com

Locations
United States, New Jersey
Neurology Group of Bergen County Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Peter L Heilbroner, MD, PhD            
Sponsors and Collaborators
Neurology Group of Bergen County, P.A.
Shire Development LLC
  More Information

No publications provided

Responsible Party: Peter L. Heilbroner M.D. PHD, Neurology Group of Bergen County, P.A.
ClinicalTrials.gov Identifier: NCT01146002     History of Changes
Other Study ID Numbers: Guanfacine learning study
Study First Received: June 15, 2010
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurology Group of Bergen County, P.A.:
Attention-deficit/hyperactivity disorder, primarily inattentive or combined type.

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
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 June 17, 2013