Status:
TERMINATED
Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Lead Sponsor:
Children's Specialized Hospital
Collaborating Sponsors:
Shire
Conditions:
Attention-Deficit/Hyperactivity Disorder
Attention Deficit Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01156051
Start Date
June 1 2010
End Date
February 1 2012
Last Update
August 11 2014
Active Locations (2)
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1
Children's Specialized Hospital
Hamilton, New Jersey, United States, 08619
2
Children's Specialized Hospital
Toms River, New Jersey, United States, 08755