Efficacy and safety of 2 mg/day M100907 on Sleep Maintenance Insomnia: a 6-week, multicenter, randomized, double-blind, placebo-controlled Polysomnographic study - Nocturne 907 (NPSG study of M100907)

Phase 1

Conditions: Sleep maintenance insomnia
MedDRA version: 9.1Level: LLTClassification code 10022437Term: Insomnia
MedDRA version: 9.1Level: PTClassification code 10022437Term: Insomnia

Registration Number: EUCTR2006-005303-34-FR

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 580

Inclusion Criteria

Related to patients:
1.Out-patients = 18 years of age or the legal age of consent in the area where the study is being done.
2.Woman of childbearing potential (less than two years post-menopausal or not surgically sterile), must have a negative urine pregnancy test at screening - and must use a highly effective method of birth control for at least one month prior to screening, which is defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs containing hormones, sexual abstinence (unless not acceptable by the local health authorities) or vasectomised partner.

Related to sleep disorders:
3.Each patient must have primary insomnia based on criteria (DSM IV-TR) with predominant complaints of difficulty in maintaining sleep (nocturnal awakenings or early morning awakenings), 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 must complain of at least one hour of wakefulness after sleep onset for at least 4 or more nights per week over the preceding month.
5.Based on patient’s information, the patient must have spent at least 6.5 hours and not more than 9.0 hours, in bed, over the preceding two weeks.
6.Patient must report an impact on daytime functioning associated with sleep maintenance insomnia as measured by question 3 of Insomnia Severity Index at screening and randomization visits. To be included patient’s answer should be either: 2 (= Somewhat interfering), or 3 (= Much), or 4 (= Very Much Interfering).
7.Based on the NPSG recordings during the screening nights (SN1 and SN2) the following criteria must be present:
•Mean NPSG -WASO of SN1 and SN2 is = 45 min and neither night should be < 30 min.
•TST = 7 hours and = 3 hours on both screening nights (SN1 or SN2).
•Mean LPS calculated on SN1 and SN2 = 30min.

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 patients:
1.Females who are lactating or who are pregnant.
2.Night shift workers, and individuals who nap 3 or more times per week over the preceding month.
3.Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day.
4.Participation in another trial having received study medication within one month before the screening visit.
5.Body mass index = 33 calculated from patient’s height (m) and weight (kg); weight (kg)/height (m²).
6.Apnea / Hypopnea Index (AHI) = 10 per hour.
7.Periodic limb movements associated with arousal Index (PLMAI) = 10 per hour.
8.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 supplement with valerian root) or prescription sleep medication, including hynotics and sedatives, and anxiolytics, within one week or five half-lives (whichever is longer), prior to screening.
9.Use of any substance with psychotropic effects or properties known to affect sleep/wake, including, but not limited to: neuroleptics, morphone/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, within one week or five half-lives (whichever is longer), prior to screening.
10.Patients unable to complete the study questionnaire.
11.Patients unwilling to provide written, signed and dated informed consent must not be included in the study.
12.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.
13.Based on medical history and /or NPSG: (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep disorder (apnea-hypopnea index = 10/hour of sleep), (iv) circadian rhythm sleep disorder, (v) parasomnia (e.g. somnambulism), (vi) dyssomnia not otherwise specified, i.e. periodic leg movement syndrome (A leg movement is defined as a burst of anterior tibialis muscle activity with a duration between onset and resolution of 0.5-5.0 seconds, with an amplitude of at least 25% of the baseline amplitude. The leg movement must be separated from a subsequent leg movement by at least 5 seconds and not more than 90 seconds. The leg movement must be associated with an arousal or awakening to be considered an event, and the arousal/awakening must follow the leg movement onset by not more than 3 seconds. Periodic leg movement exclusion criterion is defined as a PLMAI = 10 events/hour of sleep. Leg movements associated with wake” and respiratory events” are not counted).
Related to concomitant illnesses:
14.Patients presenting with acute or chronic pain resulting in insomnia.
15.Patients with current psychiatric disturbances according to DSM IV 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.
16.Patients with mental retardation or dementia.
17.Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions).
18.Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may inte

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of M100907 - 2 mg/day in comparison to placebo for Sleep Maintenance Insomnia using change from baseline at 6 weeks of treatment of night polysomnography (NPSG) wake time after sleep onset (WASO).<br>;Primary end point(s): Change from baseline to week 6 of the mean NPSG -WASO.;Secondary Objective: - Efficacy vs placebo in improving patient’s daytime functioning change from baseline to 6 weeks in the General Productivity” Domain score of the Functional Outcomes of Sleep Questionnaire (FOSQ). <br>- Effect on sleep (pr-WASO and sleep architecture)<br>- Clinical safety and tolerability, residual effects and effect on sleep following abrupt discontinuation after 6 weeks of treatment<br>

Secondary Outcome Measures

Name	Time	Method

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