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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

July 1, 2010
July 21, 2014
June 2010
February 2012   (final data collection date for primary outcome measure)
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
Change in baseline to treatment polysomnographic latency to persistent sleep time [ Time Frame: five to six weeks ] [ Designated as safety issue: No ]
Change in objective measures of sleep, using polysomnography
Complete list of historical versions of study NCT01156051 on ClinicalTrials.gov Archive Site
  • 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.
  • Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total score [ Time Frame: five to six weeks ] [ Designated as safety issue: No ]
    Evaluation of ADHD symptoms as reported on clinical interview
  • Change in baseline to treatment total sleep time on polysomnography [ Time Frame: five to six weeks ] [ Designated as safety issue: No ]
    Change in objective measures of sleep, using polysomnography
  • Change in baseline to treatment ADHD-Rating Scale IV (School Version) total score [ Time Frame: five to six weeks ] [ Designated as safety issue: No ]
    Evaluation of ADHD symptoms as reported by teacher observation, as recorded on a standardized checklist
Not Provided
Not Provided
 
Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Attention-Deficit/Hyperactivity Disorder
  • Attention Deficit Disorder
  • Insomnia
  • Sleep Disorders
  • 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
  • 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"
  • Experimental: Guanfacine Extended-Release Tablets
    Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
    Intervention: Drug: Guanfacine extended-release tablets
  • Placebo Comparator: Placebo comparator
    Placebo control
    Intervention: Drug: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01156051
CSHTR-TR-0901
Yes
Thomas Rugino, Children's Specialized Hospital
Children's Specialized Hospital
Shire
Principal Investigator: Thomas A Rugino, MD Children's Specialized Hospital
Children's Specialized Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP