E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the impact of an evening dose of eszopiclone on next day performance in a standardised test of automobile driving by measuring brake reaction time. |
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E.2.2 | Secondary objectives of the trial |
To investigate the impact of an evening dose of eszopiclone on next day performance using psychometric assessments. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Aged between 18 and 55 years inclusive
2.In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
3.Diagnostic and statistical manual of mental disorders, (fourth edition DSM-IV) defined primary insomnia
4.Able and willing to give written informed consent
5.A body mass index greater than or equal to 18 and less than or equal to 30 6.Registered with a general practitioner (GP)
7.Hold a full current driving licence for at least one year, and be regular car drivers
8.Upon questioning, a Sleep Latency (time to fall asleep) of 30 minutes or greater per night
9.Upon questioning a Total Sleep Time of 6.5 hours or less per night
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E.4 | Principal exclusion criteria |
1.Concomitant psychotropic medication (see Appendix II for details of non permitted medication).
2.The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication.
3.Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea)
4.Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
5.Significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological or haematological disease or abnormality
6.Defined laboratory, biochemical, haematological abnormalities not including isolated abnormalities that are considered to be clinically insignificant by the physician
7.Any subject with known hypersensitivity to any of the study treatments
8.A sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study
9.Pregnant or lactating females, and females of child bearing potential not using effective contraception
10.Patients who habitually smoke more than 5 cigarettes per day
11.Caffeine consumption of more than 5 cups or glasses per day
12.History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males
13.Current participation in another clinical trial, or participation in a clinical trial within the last 90 days
14.Any subject that the physician, or investigator judges to be unsuitable
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary measure is the assessment of mean of brake reaction time (BRT) following illumination of the red lamp.
The secondary measures of efficacy to assess the effects on cognitive and psychomotor function are: Compensatory Tracking Test (CTT): mean deviation (pixels), peripheral reaction time (ms) Sternberg’s Short-Term Memory Scanning Test (STM): mean reaction time (ms) Rapid Visual Information Processing (RVIP): number of valid responses and the mean valid response time Critical Flicker Fusion (CFF): mean CFF threshold (Hz) Choice Reaction Time (CRT): recognition reaction time (RRT, ms) motor reaction time (MRT, ms), and total reaction time (TRT, ms) LARS: Factors determined by factor analysis LSEQ: Ease of Getting to Sleep, Quality of Sleep, Early Morning Awakenings and Behaviour Following Wakening (units) Digit Symbol Substitution Test: number of total responses, number of correct responses
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |