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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00253968