Insomnia characterized by sleep maintenance difficulties MedDRA version: 11.0 Level: LLT Classification code 10027590 Term:
Conditions
Interventions
Product Name: Volinanserin
Product Code: M100907
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: volinanserin
CAS Number: 139290-65-6
Current Sponsor code: M100907
Concentration unit: mg
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written, signed and dated informed consent obtained (for patients accepting pharmacogenetic testing, specific written, signed and dated informed consent obtained); 2. Primary Insomnia according to DSM-IV-TR criteria (Appendix A), with predominantly difficulty in maintaining 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: •Exclusion criteria related to study methodology 1. Patients younger than 18 years; 2. Inpatients; 3. 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; 4. Based on patient’s information, the patient complains of less than one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month; 5. Based on patient’s sleep questionnaire administered each morning during the run-in period, mean pr-WASO 7 hours or 30 min (calculated on at least 4 nigths); 8. Women of childbearing potential (less than 2 years of postmenopausal or not surgically sterile) without a negative urine ß-hCG test prior to entry into the study and who do not employ an acceptable method of birth control for this study for one month prior to entry into the run-in, throughout the study, and one month after study medication administration is stopped. Acceptable methods are the following: IUDs, depot, implant and trans-dermal estrogens-progesterones alone, combined oral contraceptives, sterilization, and double barrier methods in conjonction with permicide, vasectomized partner, and sexual abstinence. (Unless not acceptable by local health authorities); 9. Females who are pregnant or breastfeeding; 10. Night shift workers and individuals who nap 3 or more times per week over the preceding month (a nap being defined by an intentional sleep of more than 20 minutes); 11. Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day; 12. Patient unable to participate for the entire duration of the study or unable to complete study questionnaires or, in the opinion of the investigator has the potential to be non compliant with the obligations inherent in trial participation; 13. Participation in another clinical trial within 1 month before the screening visit; 14. Participation (randomization) in a previous volinanserin trial; 15. Based on medical history and patient’s information: primary hypersomnia, narcolepsy, breathing related sleep disorders, circadian rhythm sleep disorder, parasomnia (e.g., somnambulism), dyssomnia not otherwise specified (i.e., periodic leg movement); 16. Current severe neuropsychiatric disorders (i.e., psychosis, obsessive compulsive disorder, major depression, anxiety disorders, panic disorders, dementia of Alzheimer’s or vascular type) according to DSM-IV-TR criteria or mental retardation; 17. Insomnia secondary to a general medical condition; 18. Substance dependence or substance abuse within the last year (except nicotine, DSM-IV-TR criteria); 19. Acute or unstable chronic disease that in the opinion of the Investigator, would compromise the patient’s safety or successful participation in the study or that might interfere with the evaluation of study medication; 20. Evidence of any significant laboratory or ECG finding at screening which the investigator judges incompatible with the investigation of a new chemical entity; 21. Use of any over-the-counter (OTC) medications (including tryptophan, valerian, kavakava, melatonin and St John’s Wort) or prescription sleep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient’s sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.;Secondary Objective: • To compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation. • To compare the efficacy of both products on subjective sleep parameters (patient reported (pr)-Wake time After Sleep Onset (WASO), pr-Total Sleep Time (TST), pr-Number of Awakenings (NAW), pr-Sleep Onset Latency (SOL), Quality of Sleep (QoS), refreshing. (QoS) • To compare the effects of both products on patient’s daytime functioning using the Sleep Impact Scale (SIS) after 4 weeks of treatment.;Primary end point(s): Sleepiness in the morning measured on a visual analog scale of the patient’s sleep questionnaire. (“Do you feel sleepy this morning?”, 100 mm-VAS: very sleepy – not at all sleepy). | — |
Countries
France, Netherlands, Spain, Sweden
Outcome results
None listed