Phase 3
Completed N=91
An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
Healthy Subjects · Sleep Initiation and Maintenance Disorders
Source: ClinicalTrials.gov NCT00699608 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
May 2010
Primary outcomePrimary: Mean Tracking Error Assessed During the Continuous Tracking Test (CTT) — 10.29; 12.49; 13.48 pixels — p=0.267
Summary
This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Tracking Error Assessed During the Continuous Tracking Test (CTT) |
10.29; 12.49; 13.48 | 0.267 |
| SECONDARY Mean Tracking Error (MTE) Assessed During the CTT |
10.20; 12.80; 13.07; 9.70; 12.72; 13.15 | — |
| SECONDARY CTT Mean Reaction Time |
746.88; 791.99; 806.31; 744.90; 787.41; 799.53 | — |
| SECONDARY Critical Flicker Fusion Test-Ascending Threshold |
30.65; 30.84; 30.93; 30.31; 30.30; 30.41 | — |
| SECONDARY Critical Flicker Fusion Test -Descending Threshold |
29.06; 28.37; 28.05; 28.52; 27.95; 27.95 | — |
| SECONDARY Critical Flicker Fusion Test-Overall Threshold |
29.82; 29.57; 29.45; 29.41; 29.11; 29.00 | — |
| SECONDARY Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test |
68.2; 64.7; 63.4; 70.4; 66.5; 65.6 | — |
| SECONDARY Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test |
67.9; 64.3; 63.0; 70.2; 66.2; 65.2 | — |
| SECONDARY 1-Back Percentage of Correct Responses |
93.9; 92.2; 90.4; 93.3; 92.0; 89.5 | — |
| SECONDARY 3-Back Percentage of Correct Responses |
84.6; 80.4; 76.9; 83.5; 82.3; 76.8 | — |
| SECONDARY 1-Back Reaction Time |
755.9; 819.3; 840.3; 752.7; 783.7; 805.8 | — |
| SECONDARY 3-Back Reaction Time |
959.5; 1020.9; 1076.4; 960.0; 1018.5; 1042.2 | — |
| SECONDARY Sedation Score, as Assessed by the Linear Analogue Rating Scales |
54.21; 54.87; 57.00; 54.54; 56.40; 59.21 | — |
| SECONDARY Mood Score, as Assessed by the Linear Analogue Rating Scales |
47.75; 48.13; 48.03; 49.19; 48.42; 49.11 | — |
| SECONDARY Coordination Score, as Assessed by the Linear Analogue Rating Scales |
49.09; 50.33; 52.42; 50.03; 51.21; 52.10 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Healthy male and female subjects providing written informed consent.
EXCLUSION CRITERIA
- 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.
Data sourced from ClinicalTrials.gov (NCT00699608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.