Expired Study
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Bridgewater, New Jersey 08807


Purpose:

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.


Criteria:

Inclusion Criteria: - Diagnosis of primary insomnia based on DSM-IV-TR 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.


NCT ID:

NCT00805350


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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