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:
Children's Specialized Hospital
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
Thomas Rugino, Children's Specialized Hospital
ClinicalTrials.gov Identifier:
NCT01156051
First received: July 1, 2010
Last updated: March 29, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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
Secondary Outcome Measures:
- 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
| Enrollment: | 32 |
| 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:
- 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.
Contacts and Locations
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 Development LLC
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 |
| Last Updated: | March 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Specialized Hospital:
|
ADHD ADD sleep disturbance |
Additional relevant MeSH terms:
|
Sleep Disorders Parasomnias Attention Deficit Disorder with Hyperactivity Hyperkinesis Sleep Initiation and Maintenance Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Dyskinesias Sleep Disorders, Intrinsic |
Dyssomnias 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 18, 2013