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

Primary Insomnia Clinical Trial

— ECLIPSE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805350
• Other study ID #: EFC10844
• Secondary ID: 2008-003791-22
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2008
• Last updated: February 5, 2016
• Start date: December 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of treatment : 6 weeks

Duration of observation: 9 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia

Intervention

Drug:
• Eplivanserin
one 5 mg tablet once a day
• Placebo
Placebo of Eplivanserin one tablet once a day

Locations

Country	Name	City	State
Austria	Sanofi-Aventis Administrative Office	Wien
Canada	Sanofi-Aventis Administrative Office	Laval
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Hungary	Sanofi-Aventis Administrative Office	Budapest
Poland	Sanofi-Aventis Administrative Office	Warszawa
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of mean PSG-WASO on N41/N42		6 weeks	No
Primary	Change from baseline of mean PSG-NAW on N41/N42		6 weeks	No
Secondary	Other PSG sleep parameters: PSG-TST, PSG-SE (TST/Time in Bed), PSG-LPS		6 weeks	No
Secondary	Patient-reported sleep parameters		6 weeks	No
Secondary	Patient Global impression (PGI)		6 weeks	Yes
Secondary	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	Yes
Secondary	Sleep Impact Scale (SIS)		6 weeks	Yes
Secondary	SF-36 Health Survey		6 weeks	Yes