Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00857220
First received: March 4, 2009
Last updated: June 18, 2013
Last verified: June 2013
Results First Received: November 2, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Insomnia
Attention Deficit Hyperactivity Disorder
Intervention: Drug: eszopiclone

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The participant flow section includes all subjects randomized. The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. One subject did not receive study medication.

Reporting Groups
  Description
2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) Eszopiclone Overall

Participant Flow:   Overall Study
    2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)  
STARTED     304  
COMPLETED     121  
NOT COMPLETED     183  
Adverse Event                 35  
Death                 1  
Lack of Efficacy                 11  
Lost to Follow-up                 30  
Physician Decision                 4  
Protocol Violation                 16  
Withdrawal by Subject                 67  
Clinical Hold                 6  
Site Closed                 5  
Miscellaneous                 8  



  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.
No text entered.

Reporting Groups
  Description
2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) Eszopiclone Overall

Baseline Measures
    2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)  
Number of Participants  
[units: participants]
  303  
Age  
[units: participants]
 
<=18 years     303  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.2  ± 3.2  
Gender  
[units: participants]
 
Female     119  
Male     184  
Region of Enrollment  
[units: participants]
 
United States     303  



  Outcome Measures
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1.  Primary:   Overall Incidence of Adverse Events   [ Time Frame: 12 Months (from the 1st dose to the end of study) ]

2.  Secondary:   Overall Incidence of Skin Reactions: Number of Events   [ Time Frame: 12 Months (from the 1st dose to the end of study) ]

3.  Secondary:   Overall Incidence of Skin Reactions: Number of Participant Affected   [ Time Frame: 12 Months (from the 1st dose to the end of study) ]

4.  Secondary:   Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses   [ Time Frame: 12 Months ]

5.  Secondary:   Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

6.  Secondary:   Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

7.  Secondary:   Change From Baseline at Month 12 in Subjective Sleep Latency (SL)   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

8.  Secondary:   Change From Baseline in Child Behavior Checklist (CBCL)   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

9.  Secondary:   Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

10.  Secondary:   Change From Baseline in Conners’ Continuous Performance Test II (CCPT II)   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

11.  Secondary:   Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

12.  Secondary:   Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

13.  Secondary:   Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

14.  Secondary:   Change From Baseline in Pediatric Quality of Life Scale   [ Time Frame: Baseline and 12 Months (from the 1st dose to the end of study) ]

15.  Secondary:   Clinical Laboratory Assessments   [ Time Frame: Day -30 to -1, Day 0, Week 2(for treatment naive pts), and Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   Vital Sign Measurements   [ Time Frame: Day -14 to -1, Day 0, Week 2, and Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   Orthostatic Effects   [ Time Frame: Day -14 to -1, Day 0, Week 2 (for treatment naive pts) , and Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

18.  Secondary:   12 Lead ECG Parameters   [ Time Frame: Day -30 to -1, and Months 1 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

19.  Secondary:   Physical Examinations   [ Time Frame: Day -30 to -1, and Months 1, 3, 6, 9, and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

20.  Secondary:   Neurologic Examinations   [ Time Frame: Day -14 to -1, and Months 1, 3, 6, 9, and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
Designed to assess safety/tolerability. Efficacy endpoints evaluated w/ descriptive stats only, w/ no placebo group against which to assess the impact of therapy. ~40% completion rate typical for one year studies but limits interpretation of results.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: CNS Medical Director
Organization: Sunovion
phone: 866-503-6357


No publications provided


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00857220     History of Changes
Other Study ID Numbers: 190-247
Study First Received: March 4, 2009
Results First Received: November 2, 2012
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration