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

Primary Purpose

Attention-Deficit/Hyperactivity Disorder, Attention Deficit Disorder, Insomnia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Guanfacine extended-release tablets
Placebo comparator
Sponsored by
Children's Specialized Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder focused on measuring ADHD, ADD, sleep disturbance

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Specialized Hospital
  • Children's Specialized Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Guanfacine Extended-Release Tablets

Placebo comparator

Arm Description

Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg

Placebo control

Outcomes

Primary Outcome Measures

Change in Polysomnographic Total Sleep Time (TST)
Change in objective measures of sleep, using polysomnography

Secondary Outcome Measures

Change in Baseline to Treatment ADHD-Rating Scale IV Total Score
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)
Change in an objective measure of sleep onset, using polysomnography.
Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)
Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.

Full Information

First Posted
July 1, 2010
Last Updated
July 21, 2014
Sponsor
Children's Specialized Hospital
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01156051
Brief Title
Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Official Title
Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
extended beyond completion date; chose to close out rather than renew IRB review
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Specialized Hospital
Collaborators
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder, Attention Deficit Disorder, Insomnia, Sleep Disorders
Keywords
ADHD, ADD, sleep disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guanfacine Extended-Release Tablets
Arm Type
Experimental
Arm Description
Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
Placebo control
Intervention Type
Drug
Intervention Name(s)
Guanfacine extended-release tablets
Other Intervention Name(s)
Intuniv (TM), guanfacine HCl, SPD503
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Other Intervention Name(s)
"sugar pill"
Intervention Description
Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).
Primary Outcome Measure Information:
Title
Change in Polysomnographic Total Sleep Time (TST)
Description
Change in objective measures of sleep, using polysomnography
Time Frame
Baseline to last observation carried forward (after at least one week of dose stability)
Secondary Outcome Measure Information:
Title
Change in Baseline to Treatment ADHD-Rating Scale IV Total Score
Description
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).
Time Frame
Baseline to last observation carried forward (after at least one week of dose stability)
Title
Change in Baseline to Treatment Latency to Persistent Sleep (LPS)
Description
Change in an objective measure of sleep onset, using polysomnography.
Time Frame
Baseline to last observation carried forward (after at least one week of dose stability)
Title
Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)
Description
Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.
Time Frame
Baseline to last observation carried forward (after at least one week of dose stability)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must be male or female, aged 6 - 12 years with ADHD. 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. Subject must have repeated difficulty with sleep initiation or persistence despite attempts at adequate sleep hygiene. Subject must be able to swallow tablets. Exclusion Criteria: Subject or parent/LAR is unable or unwilling to discontinue present medications used to treat ADHD. Subject has a body mass index < 5th percentile for age, using the Centers for Disease Control standards reported in 2000. Subject has a body weight > 176 pounds. Subject has a diagnosis of Autism or Autism Spectrum Disorder. Subject has other serious psychiatric diagnoses. 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 Subject has an excessive caffeine intake (greater than 2.5 mg/kg/d). Subject has a prior problem with clonidine or guanfacine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Rugino, MD
Organizational Affiliation
Children's Specialized Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Specialized Hospital
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08619
Country
United States
Facility Name
Children's Specialized Hospital
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States

12. IPD Sharing Statement

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

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