An evaluation of potential next-day residual effects of eszopiclone in healthy volunteers.
Trial overview
Mean Tracking Error Assessed during the Continuous Tracking Test (CTT)
Timeframe: 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)
Mean Tracking Error (MTE) Assessed during the CTT
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
CTT Mean Reaction Time
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Critical Flicker Fusion Test–Ascending Threshold
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Critical Flicker Fusion Test –Descending Threshold
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Critical Flicker Fusion Test–Overall Threshold
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
1-Back Percentage of Correct Responses
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
3-Back Percentage of Correct Responses
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
1-Back Reaction Time
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
3-Back Reaction Time
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Sedation Score, as Assessed by the Linear Analogue Rating Scales
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Mood Score, as Assessed by the Linear Analogue Rating Scales
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Coordination Score, as Assessed by the Linear Analogue Rating Scales
Timeframe: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Participation criteria
- Healthy male and female subjects providing written informed consent.
- Significant medical disorders;
- Sleeping difficulties; alcohol and/or substance abuse;
- Healthy male and female subjects providing written informed consent.
- Significant medical disorders;
- Sleeping difficulties; alcohol and/or substance abuse;
- Recent use of psychotropic medications, or need to use them during study;
- Very high BMI or very low BMI or bodyweight;
- Known hypersensitivity to the study medications or their excipients;
- Unwilling or unable to meet certain lifestyle or dietary restrictions during the study.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.