SLEEP MAINTENANCE INSOMNIA
Conditions
Interventions
Product Name: Eplivanserin
Product Code: SR46349B
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Eplivanserin
CAS Number: SR46349B
Current Sponsor code: SR463149B
Concentration unit: mg
Sponsors
SANOFI-SYNTHELABO RECHERCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Out-patients aged =18 years. - Diagnosis of primary insomnia based on criteria (DSM-IV-TR) with predominant complaints of difficulty in initiating or maintaining sleep (nocturnal awakenings), or nonrestorative sleep for at least one month preceding the study visit. (1) Disturbances of sleep maintenance:Based on patient’ s information: - Patient has spent at least 6.5 hours and no more than 9.0 hours, in bed, each night, over the preceding two weeks. -Patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month. - Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening and randomization visits. (2) Based on the information recorded in the patient’s diary during the screening week preceding the randomization the following criteria must be present: a) Mean WASO per night = 60mn during screening period (7 days) and no period of WASO 3 hours on 3-worst screening nights. c) Mean SOL during the screening period have to be = 30mn. 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: - Females who are lactating or who are pregnant, - Woman of childbearing potential with a positive serum beta-human chorionic gonadotropin (bHCG) pregnancy test at screening and not using an acceptable form of contraception, - Patients presenting with acute or chronic pain resulting in insomnia, - Patients with current psychiatric disturbances - Patients with a history of epilepsy or seizures, with clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, with history of serious head injury or stroke - Patients with clinically significant and abnormal ECG - Use of any prescription or OTC sleep medication - Use of substances with psychotropic effects or porperties known to affect sleep/awake - Night shift workers, and individuals who nap 3 or more times per week over the preceding month, - History of (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep disorder, (iv) circadian rhythm sleep disorder, (v) parasomnia (e.g. somnambulism), (vi) dyssomnia not otherwise specified, i.e. periodic leg movement syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of eplivanserin 5mg/day in comparison to placebo after 6 and 12 weeks of treatment on Sleep Maintenance Insomnia using patient sleep questionnaires (pr-WASO).;Secondary Objective: - To evaluate patient’s daytime functioning using the Functional Outcomes of Sleep Questionnaire (FOSQ) with eplivanserin 5mg/day as compared to placebo after 6 and 12 weeks of treatment - To evaluate residual effects (using patient’s morning questionnaire) that may be associated with eplivanserin 5mg/day as compared to placebo during double-blind treatment period (after each night of treatment). -To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo after 6 and 12 weeks of treatment. Open treatment phase extension: 40 weeks duration: - To evaluate patient’s daytime functioning using the Functional Outcomes Sleep Questionnaire with eplivanserin 5mg/day during 52 weeks of treatment. - To evaluate the clinical safety of eplivanserin 5mg/day during the 52 weeks with eplivanserin treatment. - To assess the effect on sleep following abrupt discontinuation (after 52 weeks) of study treatment with eplivanserin 5mg/day (during run-out period).;Primary end point(s): Wake time after sleep onset using patient's sleep questionnaire (pr-WASO) | — |
Countries
Czech Republic, Finland, Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed