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
Results First Received: May 31, 2014  
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
Conditions: Attention-Deficit/Hyperactivity Disorder
Attention Deficit Disorder
Insomnia
Sleep Disorders
Interventions: Drug: Guanfacine extended-release tablets
Drug: Placebo comparator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Medications for ADHD, that would affect sleep/alertness, or that had psychoactive properties were discontinued prior to polysomnography. Of the 35 who entered screening, 29 were enrolled. Children were disquialified for not meeting diagnostic criteria or for having disqualifying conditions (e.g., depression, heart pathology).

Reporting Groups
  Description
Treatment Group Children who received (double blinded, randomized) guanfacine extended release tablets in a flexible dosing protocol, with doses ranging from 1mg to 4mg administered once daily in the morning.
Control Children who received a matching placebo tablet administered once daily in the morning in a flexible dosing protocol, with tablets identical to guanfacine extended release from 1mg to 4mg.

Participant Flow:   Overall Study
    Treatment Group     Control  
STARTED     12     17  
COMPLETED     11     16  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 0  
patient not compliant with protocol                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
29 enrollees, but two were excluded due to (1) lost to follow up, and (2) noncompliance with the protocol.

Reporting Groups
  Description
Guanfacine Extended-Release Tablets

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

Guanfacine extended-release tablets: Guanfacine extended-release tablets were started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated

Placebo Comparator

Placebo control

Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg were started and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated

Total Total of all reporting groups

Baseline Measures
    Guanfacine Extended-Release Tablets     Placebo Comparator     Total  
Number of Participants  
[units: participants]
  11     16     27  
Age  
[units: years]
Mean ± Standard Deviation
  9.1  ± 1.8     8.8  ± 1.9     8.9  ± 1.9  
Gender  
[units: participants]
     
Female     2     8     10  
Male     9     8     17  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     2     2  
Not Hispanic or Latino     11     14     25  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
White     10     12     22  
African-American     1     4     5  
Region of Enrollment  
[units: participants]
     
United States     11     16     27  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Polysomnographic Total Sleep Time (TST)   [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas A Rugino MD
Organization: Children's Specialized Hospital
phone: 732-797-3826
e-mail: trugino@childrens-specialized.org


No publications provided


Responsible Party: Thomas Rugino, 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
Results First Received: May 31, 2014
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration