Efficacy and safety of eplivanserin 5mg/day in insomnia characterized by sleep maintenance difficulties: a 6-week, randomized, double-blind, placebo-controlled, polysomnography study - ECLIPSE

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Written, signed and dated informed consent obtained.
2. Primary insomnia based on DSM-IV-TR with difficulty initiating or maintaining sleep, 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.
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

1. Based on patient’s information, the patient has spent less than 6.5 hours or more than 9.0 hours, in bed, each night, over the preceding two weeks
2. Based on patient’s information, the patient complains of less than 1 hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month
3. Patient responds to question 3 of Insomnia Severity Index at screening visit and randomization visit either: 0 (=Not at all interfering), or 1 (=A little interfering).
4. Mean screening PSG-WASO: calculated on SN1 and SN2 < 45mn, or a screening night with PSG-WASO < 30mn
5. Mean screening PSG-Total Sleep Time: calculated on SN1 and SN2 =7 hours or =3 hours
6. Mean screening PSG-Latency to Persistent Sleep: calculated on SN1 and SN2 > 30mn
7. Patients under 18 years of age
8. In-patients
9. Patients presenting with acute or chronic pain resulting in insomnia
10. Patients with current psychiatric disturbances according to DSM-IV-TR 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
11. Body mass index >32 calculated from patient’s height (m) and weight (kg); weight (kg)/square height (m²)
12. Patients with mental retardation or dementia
13. Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions)
14. 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
15. Clinically significant and abnormal ECG (including QTcF =500ms)
16. Serious head injury or stroke within the past year
17. Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene), at screening
18. Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses/day
19. Use of any over-the-counter including tryptophan, valerian root, kava, melatonin, St John’s Wort, Alluna (herbal sleep supplement with valerian root) or prescription sleep medication, including hypnotics and sedatives (N05C), and anxiolytics (N05B), within 1 week or five half-lives (whichever is longer), prior to screening
20. 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), antihistamines (R06A), stimulants (N06B) antidepressants (N06A), clonidine, within one week or five half-lives (whichever is longer), prior to screening
21. Previous participation in a clinical trial (i.e., randomization) with eplivanserin
22. Participation in any other trial within 1 month before the screening visit
23. Patients unable to complete the study questionnaire
24. Patients who are unable to participate for the entire duration of the study, or in the opinion of the investigator, are likely to be non-compliant with the obligations inherent in the trial participation
25. Patient not able to understand and follow the requirements of the study and to comply
26. Night shift workers, and individuals who nap 3 or more times per week over the preceding month
2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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