Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2008 |
| End Date: | June 2009 |
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties: a 6-week, Randomized, Double-blind, Placebo-controlled, Polysomnography Study.
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.
- 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.
Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of
treatment : 6 weeks
Duration of observation: 9 weeks
treatment : 6 weeks
Duration of observation: 9 weeks
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.
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