Chronic primary insomnia and sleep maintenance difficulties.
Conditions
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Outpatients, aged 18 years and above. • Primary Insomnia according to DSM-IV-TR criteria. • Based on patient’s information, the patient must have complained of at least 1 hour of wakefulness for at least 3 nights per week during the preceding month. • Based on patient’s information, the patient must have spent at least 6.5 hours and not more than 9 hours in bed (time in bed = TIB) trying to sleep, each night during the preceding 2 weeks. • Based on patient’s sleep questionnaire administered each morning during the run-in period, patients must have had the following (calculated on at least 4 nights): - a mean pr-WASO = 45 min, - a mean pr-TST 3 hours, - a mean pr-SOL = 30 min. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Exclusion criteria related to study methodology - Refusal or inability to give written, signed and dated informed consent to participate in the study. - Women of childbearing potential (less than 2 years of postmenopausal or not surgically sterile) without a negative urine ß-hCG test prior to entry into the study and who do not employ an acceptable method of birth control for this study for one month prior to entry into the run-in, throughout the study, and one month after study medication administration is stopped. Acceptable methods are the following: IUDs, depot, implant and trans-dermal estrogens-progesterones alone, sterilization, and double barrier methods in conjunction with spermicide alone or added to oral contraceptives, sexual abstinence. - Females who are pregnant or breastfeeding. - Night shift workers and individuals who nap 3 or more times per week over the preceding month (a nap being defined by an intentional sleep of more than 20 minutes). - Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day. - Patient unable to participate for the entire duration of the study or unable to complete study questionnaires or, in the opinion of the investigator has the potential to be non compliant with the obligations inherent in trial participation. - Participation in another clinical trial within 1 month before the screening visit. - Based on medical history and patient’s information: primary hypersomnia, narcolepsy, breathing related sleep disorders, circadian rhythm sleep disorder, parasomnia (e.g., somnambulism), dyssomnia not otherwise specified (i.e., periodic leg movement). - Current severe neuropsychiatric disorders (i.e., psychosis, obsessive compulsive disorder, major depression, anxiety disorders, panic disorders, dementia of Alzheimer’s or vascular type) according to DSM-IV-TR criteria or mental retardation. - Insomnia secondary to a general medical condition. - Substance dependence or substance abuse within the last year (except nicotine, DSM-IV-TR criteria). - Acute or unstable chronic disease that in the opinion of the Investigator, would compromise the patient’s safety or successful participation in the study or that might interfere with the evaluation of study medication. - Evidence of any significant laboratory or ECG finding at screening which the investigator judges incompatible with the investigation of a new chemical entity. - Use of any over-the-counter (OTC) medications (including tryptophan, valerian, kava-kava, melatonin and St John’s Wort) or prescription sleep medications including hypnotics and sedatives (N05C) and anxiolytics (N05B) within 1 week or 5 half-lives (whichever is longer) before screening. - Use of any substance with psychotropic effects or properties known to affect sleep/wake, including but not limited to: antipsychotics (N05A), morphine/opioid derivatives (N02A), antihistaminics (R06A), stimulants (N06B), antidepressants (N06A), clonidine, within 1 week or 5 half-lives (whichever is longer) before screening. • Exclusion criteria related to lormetazepam - Certain muscular disorders (i.e.; myasthenia gravis). - Narrow angle glaucoma. - Hypersensitivity to benzodiazepines. - Sleep apnea syndrome. • Exclusion criteria related to eplivanserin - Severe respiratory and/or severe hepatic insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient’s sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.;Secondary Objective: • To compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation. • To compare the efficacy of both products on subjective sleep parameters (patient reported (pr)-Wake time After Sleep Onset (WASO), pr-Total Sleep Time (TST), pr-Number of Awakenings (NAW), pr-Sleep Onset Latency (SOL), Quality of Sleep (QoS), refreshing QoS). • To compare the effects of both products on patient’s daytime functioning using the Functional Outcome Sleep Questionnaire (FOSQ) and the Sleep Impact Scale (SIS) after 4 weeks of treatment. ;Primary end point(s): • Sleepiness in the morning measured on a visual analog scale of the patient’s sleep questionnaire. (“Do you feel sleepy this morning?”, 100 mm-VAS: very sleepy – not at all sleepy). | — |
Countries
Estonia, Finland, France, Netherlands, Portugal, Spain
Outcome results
None listed