Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia

Insomnia Clinical Trial

— GEMS  

Official title:

Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253968
• Other study ID #: LTE6217
• Secondary ID: 2005-003080-23
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2005
• Last updated: February 2, 2016
• Start date: November 2005
• Est. completion date: January 2008

Study information

• Verified date: February 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

Description:

12 weeks for each patient (double-blind period) + 1 week of run-in (placebo), and 2 weeks of run-out (placebo)

Total Duration of observation: 15 weeks for each patient

Recruitment information / eligibility

• Status: Completed
• Enrollment: 967
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Out patients

• Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I (Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition-Text Revision) criteria

• Based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month

• Patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening visit and randomization visit.

Exclusion Criteria:

• Females who are lactating or pregnant

• Woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception

• Patients presenting with acute or chronic pain resulting in insomnia

• Patients with history of epilepsy or seizures

• Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day

• Evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety

• BMI >32

• Acute or chronic pain resulting in insomnia

• Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental retardation, or dementia

• Clinically significant and abnormal EKG (QTc interval >=500 msec)

• Positive for hepatitis B or C

• Serious head injury or stroke within 1 year

• Use of OTC (over-the-counter) medications such as valerian root, kava, melatonin, St. John's Wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives

• Participation in another trial within two month before the screening visit

• Use of any substance with psychotropic effects or properties known to affect sleep/wake

• Unable to complete the study questionnaires

• Night shift workers, and individuals who nap 3 or more times per week over the preceding month

• History of:

• Primary hypersomnia

• Narcolepsy

• Breathing-related sleep disorder (such as sleep apnea)

• Circadian rhythm sleep disorder

• Parasomnia (somnambulism)

• Dyssomnia (such as periodic leg movements)

Study Design

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Eplivanserin
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Australia	Sanofi-Aventis Administrative Office	Macquarie Park
Canada	Sanofi-Aventis Administrative Office	Laval
Chile	Sanofi-Aventis Administrative Office	Santiago
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Mexico	Sanofi-Aventis Administrative Office	Mexico
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Spain	Sanofi-Aventis Administrative Office	Barcelona
United Kingdom	Sanofi-Aventis Administrative Office	Guildford
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  Czech Republic,  France,  Germany,  Mexico,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)		at week 12	No
Secondary	Change from baseline of the mean of the FOSQ (Functional Outcome of Sleep Questionnaire) items 1 and 2 (concentration/memory)		at week 12	No
Secondary	Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work)		at week 12	No