insomnia characterized by sleep maintenance difficulties MedDRA version: 11.0 Level: LLT Classification code 10027590 Term:
Conditions
Interventions
Product Name: Eplivanserin
Product Code: SR46349
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Eplivanserin
CAS Number: 130580-02-8
Current Sponsor code: SR46349B
Concentration unit: m
Sponsors
sanofi-aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW).;Primary end point(s): •Change from baseline of mean PSG-WASO on N41/N42. •Change from baseline of mean PSG-NAW on N41/N42.;Secondary Objective: •To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings and reported by patients •To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo •To evaluate the effect of eplivanserin 5mg/day on daytime functioning, as compared with placebo after 6 weeks of treatment •To evaluate patient’s impression of treatment effects •To evaluate the potential for next-day residual effects with eplivanserin 5mg/day as compared to placebo •To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo •To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia •To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo | — |
Countries
Austria, France, Germany, Hungary, Poland
Outcome results
None listed