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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00253968




Registration number
NCT00253968
Ethics application status
Date submitted
14/11/2005
Date registered
15/11/2005
Date last updated
1/03/2016

Titles & IDs
Public title
Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia
Scientific title
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study
Secondary ID [1] 0 0
2005-003080-23
Secondary ID [2] 0 0
LTE6217
Universal Trial Number (UTN)
Trial acronym
GEMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Initiation and Maintenance Disorders 0 0
Insomnia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eplivanserin
Treatment: Drugs - placebo

Experimental: Eplivanserin - Eplivanserin 5 mg/day

Placebo Comparator: Placebo - Placebo of Eplivanserin 5 mg /day


Treatment: Drugs: Eplivanserin
oral administration

Treatment: Drugs: placebo
oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
Timepoint [1] 0 0
at week 12
Secondary outcome [1] 0 0
Change from baseline of the mean of the FOSQ (Functional Outcome of Sleep Questionnaire) items 1 and 2 (concentration/memory)
Timepoint [1] 0 0
at week 12
Secondary outcome [2] 0 0
Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work)
Timepoint [2] 0 0
at week 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
967
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Canada
State/province [3] 0 0
Laval
Country [4] 0 0
Chile
State/province [4] 0 0
Santiago
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Praha
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Mexico
State/province [8] 0 0
Mexico
Country [9] 0 0
Netherlands
State/province [9] 0 0
Gouda
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00253968
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries