Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties (ECLIPSE)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00805350
First received: December 4, 2008
Last updated: November 29, 2010
Last verified: November 2010
  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.

Condition Intervention Phase
Primary Insomnia
Drug: Eplivanserin (SR46349)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties: a 6-week, Randomized, Double-blind, Placebo-controlled, Polysomnography Study.

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline of mean PSG-WASO on N41/N42 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of mean PSG-NAW on N41/N42 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS; 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]). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Patient-reported sleep parameters measured on patient sleep questionnaire: pr-WASO, pr-NAW, pr-TST, QoS, RQoS. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Residual effects measured by psychometric tests DSST & RAVLT in the morning and evening following nights in sleep lab, and reported by patients on sleep questionnaires (morning sleepiness, ability to concentrate in the morning). [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 637
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Eplivanserin (SR46349)
one 5 mg tablet once a day
Placebo Comparator: 2 Drug: Placebo
one tablet once a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805350

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Austria
Sanofi-Aventis Administrative Office
Wien, Austria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00805350     History of Changes
Other Study ID Numbers: EFC10844, EudraCT 2008-003791-22
Study First Received: December 4, 2008
Last Updated: November 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Insomnia
Sleep Maintenance
Polysomnography

Additional relevant MeSH terms:
SR 46349B
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014