Trial Information

Summary: Efficacy and safety of 2 mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a 12 week, multi-center, randomized, double-blinded, placebo-controlled study

Insomnia Do you wake up frequently during the night and have trouble getting back to sleep? Over a period of time, a lack of sleep may cause a variety of health related problems, many of which can be serious. If you are 18 years of age or older, have difficulty staying asleep and experience tiredness, a lack of energy, difficulty concentrating, or irritability during the day, you may be eligible for a research study evaluating the safety and effectiveness of an investigational drug for the treatment of insomnia. Qualified participants will receive study related medication, laboratory tests and ongoing physical exams at no charge.

Patient Inclusion Criteria:

• Outpatients aged =18 years or legal age of consent in the country where the study is being done.
• Diagnosis of primary insomnia based on criteria (DSM IVTR) with predominant complaints of difficulty maintaining sleep (nocturnal awakenings or early morning awakening) 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.
• Disturbances of sleep maintenance criteria: Based on patient’s information:
  • 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.
  • Patient has spent at least 6.5 hours and no more than 9.0 hours, in bed, each night, over the preceding two weeks.
  • Patients must report impact 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), or 3(=Much), or 4(=Very Much Interfering). Based on the information recorded in the patient’s sleep questionnaire during the screening week preceding the randomization the following criteria must be present:
  • In the Screening Period (5 – 10 days) more than a half (>50%) of nights must have WASO=60 min.
  • Total Sleep Time (TST) = 7 hours and = 3 hours on 3-worst screening nights.
  • Excluding one night in the Screening Period (5 – 10 days), with the highest Sleep Onset Latency (SOL) value, the mean SOL must be = 30 min.
  INCLUSION CRITERIA FOR PATIENTS DIAGNOSED WITH TYPE II DIABETES MELLITUS:
• Patients with type II diabetes may be included if they have an established medical diagnosis of type II diabetes mellitus (World Health Organization definition [1]), and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening).
• Instructions for patients with type II diabetes
  • After screening, diabetic patients should continue their pre-study regime of diet and exercise
  • Antidiabetic medications should not be changed unless clinically indicated

Patient Exclusion Criteria:

Related to patients:

1. Females who are lactating or who are pregnant.

2. Night shift workers, and individuals who nap3 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. 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 hypnotics and sedatives, and anxiolytics, within one week or five half-lives (whichever is longer), prior to screening.

7. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including, but not limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, within one week or five half-lives (whichever is longer), prior to screening.

8. Patients unable to complete the study questionnaires.

9. Patients unwilling to provide written, signed and dated informed consent must not be included in the study.

10. 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. Related to sleep disorders:

11. History of (i) primary hypersomnia, (ii) narcolepsy, (iii) breathing-related sleep disorder, (iv) circadian rhythm sleep disorder, (v) parasomnia (e.g. somnambulism), (vi) dyssomnia not otherwise specified, i.e., periodic leg movement syndrome.

Related to concomitant illnesses:

12. Patients presenting with acute or chronic pain resulting in insomnia.

13. 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.

14. Patients with mental retardation or dementia.

15. Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions).

16. 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.

17. Clinically significant and abnormal ECG (including QTcF = 500ms).

18. Serious head injury or stroke within the past year.

19. Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene) at screening. Related to Diabetes Mellitus Type II

20. HbA1C level of = 9.5% at the Screening Visit.

21. HbA1C level of = 6.5% at the Screening Visit. (Note: diabetic patients with HbA1C level of = 6.5% may be included in the main study population).

22. Fasting Plasma Glucose = 250 mg/dL (14.0 mmol/L) at the Screening Visit. 23. Patients with poorly controlled diabetes; i.e., a history of hospitalization for ketoacidosis within the past 12 months.

For more information,

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