A Phase 4 interventional study of Guanfacine extended-release tablets and Placebo comparator in Attention-Deficit/Hyperactivity Disorder, Attention Deficit Disorder and Insomnia, sponsored by Children's Specialized Hospital. Terminated at 2 sites in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2014-08-11.
Sponsored by Children's Specialized Hospital · Phase 4, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 29 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Children's Specialized Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Drug: Guanfacine extended-release tablets
Placebo control
Drug: Placebo comparator
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
Also known as: Intuniv (TM), guanfacine HCl, SPD503
Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).
Also known as: "sugar pill"
Change in Polysomnographic Total Sleep Time (TST)
Change in objective measures of sleep, using polysomnography
Time frame: Baseline to last observation carried forward (after at least one week of dose stability)
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).
Time frame: Baseline to last observation carried forward (after at least one week of dose stability)
Change in Baseline to Treatment Latency to Persistent Sleep (LPS)
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)
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.
Time frame: Baseline to last observation carried forward (after at least one week of dose stability)
From 2010 to 2012, children were referred primarily from the outpatient practice affiliated with a community based hospital dedicated to the evaluation and management of children with special needs. Four patients were referred from community pediatricians who commonly refer to the practice.
| Milestone | Treatment Group | Control |
|---|---|---|
| Started | 12 | 17 |
| Completed | 11 | 16 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Patient not compliant with protocol | 0 | 1 |
Change in objective measures of sleep, using polysomnography
| minutes | Guanfacine Extended-Release Tablets | Placebo Comparator |
|---|---|---|
| Change in Polysomnographic Total Sleep Time (TST) | -57.32 ± 89.17 | 31.32 ± 59.54 |
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).
| units on a scale | Guanfacine Extended-Release Tablets | Placebo Comparator |
|---|---|---|
| Change in Baseline to Treatment ADHD-Rating Scale IV Total Score | -18.27 ± 11.31 | -1.69 ± 9.16 |
Change in an objective measure of sleep onset, using polysomnography.
| minutes | Guanfacine Extended-Release Tablets | Placebo Comparator |
|---|---|---|
| Change in Baseline to Treatment Latency to Persistent Sleep (LPS) | 10.54 ± 88.44 | -19.94 ± 54.12 |
Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.
| minutes | Guanfacine Extended-Release Tablets | Placebo Comparator |
|---|---|---|
| Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO) | 21.80 ± 18.51 | -3.90 ± 17.20 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Guanfacine Extended-Release Tablets | — | 0/12 (0%) | 9/12 (75%) |
| Placebo Comparator | — | 0/17 (0%) | 11/17 (64.7%) |
| Event | Guanfacine Extended-Release Tablets | Placebo Comparator |
|---|---|---|
| somnolence / sedationNervous system disorders | 8/12 | 1/17 |
| headacheNervous system disorders | 4/12 | 2/17 |
| exacerbation of allergic rhinitisRespiratory, thoracic and mediastinal disorders | 1/12 | 5/17 |
| upper respiratory infectionInfections and infestations | 3/12 | 3/17 |
| stomachache / abdominal painGastrointestinal disorders | 1/12 | 2/17 |
| acute gastroenteritisGastrointestinal disorders | 1/12 | 2/17 |
| dermatitisSkin and subcutaneous tissue disorders | 1/12 | 2/17 |
| febrile illnessInfections and infestations | 1/12 | 0/17 |
| coughRespiratory, thoracic and mediastinal disorders | 1/12 | 0/17 |
| enuresisRenal and urinary disorders | 1/12 | 0/17 |
29 enrollees, but two were excluded due to (1) lost to follow up, and (2) noncompliance with the protocol.
| Age, Continuous(years) | Guanfacine Extended-Release Tablets | Placebo Comparator | Total |
|---|---|---|---|
| Mean | 9.1 ± 1.8 | 8.8 ± 1.9 | 8.9 ± 1.9 |
| Sex: Female, Male(Participants) | Guanfacine Extended-Release Tablets | Placebo Comparator | Total |
|---|---|---|---|
| Female | 2 | 8 | 10 |
| Male | 9 | 8 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Guanfacine Extended-Release Tablets | Placebo Comparator | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 11 | 14 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Guanfacine Extended-Release Tablets | Placebo Comparator | Total |
|---|---|---|---|
| White | 10 | 12 | 22 |
| African-American | 1 | 4 | 5 |
| Region of Enrollment(participants) | Guanfacine Extended-Release Tablets | Placebo Comparator | Total |
|---|---|---|---|
| United States | 11 | 16 | 27 |
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Children's Specialized Hospital