Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties
NCT ID: NCT00805350
Last Updated: 2016-03-07
Study Results
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Basic Information
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COMPLETED
PHASE3
637 participants
INTERVENTIONAL
2008-12-31
2009-06-30
Brief Summary
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\- 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.
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Detailed Description
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Duration of observation: 9 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Eplivanserin
Eplivanserin 5 mg/day
Eplivanserin
one 5 mg tablet once a day
Placebo
Placebo of Eplivanserin 5 mg/day
Placebo
Placebo of Eplivanserin one tablet once a day
Interventions
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Eplivanserin
one 5 mg tablet once a day
Placebo
Placebo of Eplivanserin one tablet once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
Laval, , Canada
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Countries
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Other Identifiers
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2008-003791-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC10844
Identifier Type: -
Identifier Source: org_study_id
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