Insomnia
Conditions
Interventions
Product Name: Eszopiclone
Product Code: N/A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N/A
CAS Number: 138729-47-2
Sponsors
Sepracor Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To investigate the impact of an evening dose of eszopiclone on next day performance using psychometric assessments.; 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 | — |
Countries
United Kingdom
Outcome results
None listed