Efficacy and safety of eplivanserin 5mg/day on sleep maintenance insomnia: a 12-week multicenter, randomized, double-blind, placebo-controlled study - GEMS

Phase 1

• Conditions: Sleep maintenance insomnia

• Registration Number: EUCTR2005-003080-23-GB
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-11
• Study Completion: 2008-01-10
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 948

Inclusion Criteria

1) Out- patients,

2) Age =18 years old,

3) Each patient must have primary insomnia based on criteria (DSM-IV-TR) with
predominant complaints of difficulty in initiating or maintaining sleep (nocturnal
awakenings), or nonrestorative sleep for at least one month preceding the study visit, and having clinically significant distress or impairment in social occupational or other important areas of functioning,

4) Based on patient’s information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks,

5) 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,

6) 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. To be included patient’s answer should be either: 2 (=Somewhat interfering), or 3 (=Much), or 4 (=Very Much Interfering),

7) Based on the information recorded in the patient’s diary during the screening week preceding the randomization the following criteria must be present:
a) Mean WASO per night =60mn during screening period (7 days) and no period of
WASO < 45mn on each screening night. However, two nights with WASO < 45min during screening period are acceptable. In addition, two lowest WASO values will be excluded from the calculation of the mean WASO.
b) TST = 7 hours and = 3 hours on 3-worst screening nights.
c) Mean SOL per night have to be = 30mn during the screening period. One highest
SOL value will be excluded from the calculation of mean SOL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Related to study methodology:
1) Lactating or pregnant women
2) Woman of childbearing potential (less than two years post-menopausal or not
surgically sterile), with a positive serum beta-human chorionic gonadotropin (ßHCG) pregnancy test at screening and not using an acceptable form of contraception (e.g, birth control pill, intra-uterine device, injection of Depo-ProveraTM, double-barrier method, abstinence),
3) Patients presenting with acute or chronic pain resulting in insomnia
4) Patients with current psychiatric disturbances according to DSM-IV-TR- Axis I
criteria including but not limited to psychosis and /or bipolar disorder, obsessive
compulsive disorder, major depression, anxiety disorders, panic disorders, eating
disorder, alcohol or substance abuse or dependence –except nicotine-, or a history
of lifetime psychosis and /or bipolar disorder,
5) Body mass index >32 calculated from patient’s height (m) and weight (kg); weight
(kg)/height (m2),
6) Patients with mental retardation or dementia,
7) Patients with a history of epilepsy or seizures (not including benign neonatal and
childhood convulsions),
8) Evidence of any clinically significant, severe or unstable, acute or chronically
progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety,
9) Clinically significant and abnormal ECG (including QTc= 500ms),
10) A positive test for hepatitis B (HBs antigens) or C (HCV antibodies),
11) Serious head injury or stroke within the past year,
12) Positive qualitative urine drug screen (opiates, cocaine, amphetamine,
cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone,
propoxyphene), at screening,
13) Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day,
14) Use of any over-the-counter including tryptophan, valerian root (Valeriana
officinalis), kava (Piper methysticum Forst), melatonin, St John’s Wort
(Hypericum perforatum), Alluna (herbal sleep supplement with valerian root) or
prescription sleep medication, including hypnotics and sedatives (N05C), and
anxiolytics (N05B), within one week or five half-lives (whichever is longer), prior to screening.
15) Use of any substance with psychotropic effects or properties known to affect
sleep/wake, including, but not limited to: neuroleptics (N05A), morphine/opioid
derivatives (N02A), sedative antihistamines (R06A), stimulants (N06B)
antidepressants (N06A), clonidine, within one week or five half-lives (whichever is
longer), prior to screening,

• Related to sleep disorders:
1) Night shift workers, and individuals who nap 3 or more times per week over the
preceding month,
2) History of (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep
disorde

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified