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Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00856973
First received: March 4, 2009
Last updated: June 7, 2013
Last verified: May 2013
Results First Received: November 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Insomnia
Attention Deficit Hyperactivity Disorder
Interventions: Drug: eszopiclone
Drug: Placebo

  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
Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of participants in the Baseline Characteristics refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period. Three subjects did not receive study medication.

Reporting Groups
  Description
Pooled High Dose Eszopiclone 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Pooled Low Dose Eszopiclone 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
Placebo Placebo 6-17 years

Participant Flow:   Overall Study
    Pooled High Dose Eszopiclone     Pooled Low Dose Eszopiclone     Placebo  
STARTED     162     163     161  
COMPLETED     126     122     123  
NOT COMPLETED     36     41     38  
Adverse Event                 5                 5                 3  
Lost to Follow-up                 6                 3                 5  
Physician Decision                 0                 3                 1  
Protocol Violation                 1                 2                 1  
Withdrawal by Subject                 13                 16                 15  
Unknown                 11                 12                 13  



  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
Pooled High Dose Eszopiclone 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily. This included only patients that were randomized (ITT population).
Pooled Low Dose Eszopiclone 1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily. This includes only patients that were randomized (ITT population).
Placebo Placebo Once Daily. This included only patients that were randomized (ITT population).
Total Total of all reporting groups

Baseline Measures
    Pooled High Dose Eszopiclone     Pooled Low Dose Eszopiclone     Placebo     Total  
Number of Participants  
[units: participants]
  160     163     160     483  
Age  
[units: participants]
       
<=18 years     160     163     160     483  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     00     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.3  ± 3.0     11.4  ± 3.0     11.6  ± 3.0     11.5  ± 3.0  
Gender  
[units: participants]
       
Female     56     60     59     175  
Male     104     103     101     308  
Region of Enrollment  
[units: participants]
       
United States     160     163     160     483  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).   [ Time Frame: Baseline (Day 0) to Week 12 ]

2.  Secondary:   Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)   [ Time Frame: Baseline (Day 0) to Week 12 ]

3.  Secondary:   Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12   [ Time Frame: Baseline (Day 0) to Week 12 ]

4.  Secondary:   Change From Baseline in CGI-Child at Week 12   [ Time Frame: Baseline (Day 0) to Week 12 ]

5.  Secondary:   Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.   [ Time Frame: Baseline (Day 0) to Week 12 ]

6.  Secondary:   Change From Baseline to Week 12 in Subjective SL (Sleep Latency)   [ Time Frame: Baseline (Day 0) to Week 12 ]

7.  Secondary:   Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).   [ Time Frame: Baseline (Day 0) to Week 12 ]

8.  Secondary:   Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)   [ Time Frame: Baseline (Day 0) to Week 12 ]

9.  Secondary:   Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).   [ Time Frame: Baseline (Day 0) to Week 12 ]

10.  Secondary:   Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)   [ Time Frame: Baseline (Day 0) to Week 12 ]

11.  Secondary:   Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).   [ Time Frame: Baseline (Day 0) to Week 12 ]

12.  Secondary:   Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.   [ Time Frame: Baseline (Day 0) to Week 11 ]

13.  Secondary:   Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.   [ Time Frame: Baseline (Day 0) to Week 11 ]

14.  Secondary:   Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.   [ Time Frame: Baseline (Day 0) to Week 11 ]

15.  Secondary:   Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.   [ Time Frame: Baseline (Day 0) to Week 12 ]

16.  Secondary:   Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.   [ Time Frame: Baseline (Day 0) to Week 12 ]

17.  Secondary:   Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).   [ Time Frame: Baseline (Day 0) to Week 12 ]

18.  Secondary:   Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).   [ Time Frame: Baseline (Day 0) to Week 12 ]

19.  Secondary:   Change in School Tardiness/Attendance Reports at Week 12 (Days)   [ Time Frame: Baseline (Day 0) to Week 12 ]

20.  Secondary:   Change in School Tardiness/Attendance Reports at Week 12 (Hours)   [ Time Frame: Baseline (Day 0) to Week 12 ]


  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
Per protocol, study did not have PSG adaptation nights at baseline and contained one PSG assessment post randomization visit


  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 by Sunovion

Publications automatically indexed to this study:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00856973     History of Changes
Other Study ID Numbers: 190-246
Study First Received: March 4, 2009
Results First Received: November 2, 2012
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration