Primary Insomnia
Conditions
Keywords
Insomnia, Sleep Maintenance, Polysomnography
Brief summary
Primary objective: \- To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW). Secondary objectives: * To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS). * To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo. * To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment. * To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire. * To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo. * To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo. * To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey. * To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.
Detailed description
Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of treatment : 6 weeks Duration of observation: 9 weeks
Interventions
DRUGEplivanserin
one 5 mg tablet once a day
DRUGPlacebo
Placebo of Eplivanserin one tablet once a day
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria
Exclusion criteria
* Inpatients. * Mean screening PSG-WASO for screening night 1+ screening night 2 \< 45 mn, or screening night with PSG-WASO \< 30 mn. * Mean screening PSG-TST for screening night 1 + screening night 2 ≥7 hours or ≤3hours. * Mean screening PSG-LPS for screening night 1+ screening night 2 \> 30 mn. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of mean PSG-WASO on N41/N42 | 6 weeks |
| Change from baseline of mean PSG-NAW on N41/N42 | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global impression (PGI) | 6 weeks |
| sleep architecture: percentage of time spent in each sleep stage (1, 2, 3-4/SWS, REM), shift to stage 1, shift to wake, stage 1 + WASO, [stages 3&4]/[stage 1 + WASO]). | 6 weeks |
| Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS | 6 weeks |
| SF-36 Health Survey | 6 weeks |
| Sleep Impact Scale (SIS) | 6 weeks |
| Patient-reported sleep parameters | 6 weeks |
Countries
Austria, Canada, France, Germany, Hungary, Poland, United States
Outcome results
None listed