Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

This study has been terminated.
(extended beyond completion date; chose to close out rather than renew IRB review)
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Thomas Rugino, Children's Specialized Hospital
ClinicalTrials.gov Identifier:
NCT01156051
First received: July 1, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.


Condition Intervention Phase
Attention-Deficit/Hyperactivity Disorder
Attention Deficit Disorder
Insomnia
Sleep Disorders
Drug: Guanfacine extended-release tablets
Drug: Placebo comparator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

Resource links provided by NLM:


Further study details as provided by Children's Specialized Hospital:

Primary Outcome Measures:
  • Change in Polysomnographic Total Sleep Time (TST) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ] [ Designated as safety issue: No ]
    Change in objective measures of sleep, using polysomnography


Secondary Outcome Measures:
  • Change in Baseline to Treatment ADHD-Rating Scale IV Total Score [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ] [ Designated as safety issue: No ]
    Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total. This scale quantitates ADHD symptoms based on DSM-IV criteria with a minimum score of 0 and a maximum score of 54 (higher scores suggesting more ADHD symptoms). The total score is a sum of the 9 items on the ADHD Rating Scale IV inattention score and the 9 items on the ADHD Rating Scale IV hyperactivity-impulsivity score (scores for each 0-27).

  • Change in Baseline to Treatment Latency to Persistent Sleep (LPS) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ] [ Designated as safety issue: No ]
    Change in an objective measure of sleep onset, using polysomnography.

  • Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ] [ Designated as safety issue: No ]
    Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.


Enrollment: 29
Study Start Date: June 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guanfacine Extended-Release Tablets
Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Drug: Guanfacine extended-release tablets
Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated
Other Name: Intuniv (TM), guanfacine HCl, SPD503
Placebo Comparator: Placebo comparator
Placebo control
Drug: Placebo comparator
Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).
Other Name: "sugar pill"

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be male or female, aged 6 - 12 years with ADHD.
  2. Subject must (a) be taking methylphenidate, amphetamine, or atomoxetine for treatment of ADHD with parent or subject concerns of inadequate efficacy or intolerable side effects, or (b) free of any other medication used to treat ADHD for at least 30 days at the time of the initial sleep study.
  3. Subject must have repeated difficulty with sleep initiation or persistence despite attempts at adequate sleep hygiene.
  4. Subject must be able to swallow tablets.

Exclusion Criteria:

  1. Subject or parent/LAR is unable or unwilling to discontinue present medications used to treat ADHD.
  2. Subject has a body mass index < 5th percentile for age, using the Centers for Disease Control standards reported in 2000.
  3. Subject has a body weight > 176 pounds.
  4. Subject has a diagnosis of Autism or Autism Spectrum Disorder.
  5. Subject has other serious psychiatric diagnoses.
  6. Subject has a medical condition that may require treatment with an unapproved medication, that may cause a safety concern, or that may confound outcome results
  7. Subject has an excessive caffeine intake (greater than 2.5 mg/kg/d).
  8. Subject has a prior problem with clonidine or guanfacine.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156051

Locations
United States, New Jersey
Children's Specialized Hospital
Hamilton, New Jersey, United States, 08619
Children's Specialized Hospital
Toms River, New Jersey, United States, 08755
Sponsors and Collaborators
Children's Specialized Hospital
Shire
Investigators
Principal Investigator: Thomas A Rugino, MD Children's Specialized Hospital
  More Information

No publications provided

Responsible Party: Thomas Rugino, Principal Investigator, Children's Specialized Hospital
ClinicalTrials.gov Identifier: NCT01156051     History of Changes
Obsolete Identifiers: NCT01153178
Other Study ID Numbers: CSHTR-TR-0901
Study First Received: July 1, 2010
Results First Received: May 31, 2014
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Specialized Hospital:
ADHD
ADD
sleep disturbance

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Sleep Disorders
Parasomnias
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes
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 September 30, 2014