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

Browse trials for

• Sleep Initiation and Maintenance Disorders 1,856
• Hyperkinesis 729
• Attention Deficit Disorder with Hyperactivity 1,514

Keywords

• Hypnotic
• Eszopiclone
• Attention Deficit Hyperactivity Disorder
• Insomnia
• Children
• Adolescent

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 304 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.

Eligibility criteria

Study arms

• Experimental
  2mg eszopiclone (6-11yrs), 3mg eszopiclone (12-17yrs)

  Drug: eszopiclone

Interventions

• Drugeszopiclone

  One 2 mg tablet per day for 12 months

• Drugeszopiclone

  one 3mg tablet per day for 12 months

Primary outcomes

1. Overall Incidence of Adverse Events

   Time frame: 12 Months (from the 1st dose to the end of study)

Secondary outcomes

1. Overall Incidence of Skin Reactions: Number of Events

   Time frame: 12 Months (from the 1st dose to the end of study)

2. Overall Incidence of Skin Reactions: Number of Participant Affected

   Time frame: 12 Months (from the 1st dose to the end of study)

3. Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses

   The C-SSRS is a physician-completed scale to assess any suicidal ideation and suicidal behavior. The C-SSRS contained questions about suicidal behavior and suicidal ideation. Subjects were placed into categories for suicidal behavior and for suicidal ideation based on their responses to various questions. Any suicidality was defined as suicidal behavior or suicidal ideation. The suicidal behavior categories were determined based on the response to the questions under suicidal behavior (Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior).The suicidal ideation categories were determined by examining the response to 5 questions under suicidal ideation (Wish to be Dead, Nonspecific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent).

   Time frame: 12 Months

4. Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12

   These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6 to 7 years of age, the Coding Copy Subtest B was used for subjects 8 to 16 years of age, and the DSST was used for subjects 17 years of age. The DSST consists of rows containing small blank squares, each paired with a randomly assigned numbers 1-9. Above the rows is a key that pairs each number with a symbol. The subject must fill in the blank spaces with the matching symbol that is in the key. For the Subcopy tests the subject simply copies the symbol above each empty square. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.

   Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

5. Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12

   A 7-point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).

   Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

6. Change From Baseline at Month 12 in Subjective Sleep Latency (SL)

   Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off.

   Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

7. Change From Baseline in Child Behavior Checklist (CBCL)

   CBCL was completed by parents or guardians who saw the child in home-like settings. It includes several competence items, open-ended items for describing the child's illnesses, disabilities, concerns about the child, best things about the child, and several items to rate behavioral, emotional, and social problems. Responses are recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The checklist contains 120 questions. The standardized score is computed by determining the z-score by subtracting the mean for the subject's age group and gender from the raw score and then dividing this by the standard deviation for the subject's age group and gender. Next, multiply the zscore by 15 and then add 100. For activities scale, social scale, school scale, and total competence scale, higher values indicate higher competencies. For Internalizing problems, externalizing problems, and total problems, higher values indicate more problems.

   Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

8. Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12

   The PDSS total score ranges from a low of 0 where the individual is endorsing each item at the lowest level of daytime sleepiness to a high of 32 where the individual is endorsing each item at the highest level of daytime sleepiness.

   Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

9. Change From Baseline in Conners' Continuous Performance Test II (CCPT II)

   The CCPT-II is a computer-based 14-minute, visual-performance task. During an administration, respondents were required to press the space bar or click the mouse whenever any letter except the target letter appears on the screen. The speed at which the letters were presented varied during the administration. There were 6 blocks, with 3 sub-blocks, each containing 20 trials (letter presentations). The interstimulus intervals (ISIs) were 1, 2, and 4 seconds with a display time of 250 milliseconds. The order in which the different ISIs were presented varied between blocks. Conners' CCPT-II provides the following measures:% Omissions,% Commissions, Hit Reaction Time, Hit Reaction Time Standard Error,Variability of Standard Error, Detectability (d'), Response Style (beta), Perseverations, Hit Reaction Time Block Change (Vigilance Measure), Hit Standard Error Block Change (Vigilance Measure), Hit Reaction Time ISI change, and Hit Standard Error ISI Change, Confidence Index.

   Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

10. Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)

    The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. WASO was assessed based on the responses to the sleep questionnaire.

    Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

11. Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)

    The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. NAASO was assessed based on the responses to the sleep questionnaire.

    Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

12. Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).

    The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. TST was assessed based on the responses to the sleep questionnaire.

    Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

13. Change From Baseline in Pediatric Quality of Life Scale

    The SF-10™ Health Survey for Children is a 10-item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF-10 physical and psychosocial summary measures were scored such that higher scores indicated more favorable functioning. The Physical Summary Score is computed by summing values for questions 1, 2a, 2b, 3 and 5 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. The Psychosocial Summary Score is computed by summing questions 4, 6, 7, 8, and 9 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications.

    Time frame: Baseline and 12 Months (from the 1st dose to the end of study)

Baseline characteristics

Publications

• Sangal RB, Blumer JL, Lankford DA, Grinnell TA, Huang H. Eszopiclone for insomnia associated with attention-deficit/hyperactivity disorder. Pediatrics. 2014 Oct;134(4):e1095-103. doi: 10.1542/peds.2013-4221. PubMed 25266438 ↗