Trial Information

Summary: This is an international, multi-center, randomized, one-year (12 months), double-blind, placebo-controlled, phase II study with two parallel groups of patients with sleep maintenance insomnia.

Efficacy and safety of 2mg/day of an investigational drug on Sleep Maintenance Insomnia with a sub-study of the effect of an investigational drug on stable Type II diabetes Mellitus: A One Year, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study.

Do You Have Problems Falling Sleep And Staying Asleep? Do You Wake Up At Night Frequently? You May Suffer From Insomnia.

Amedica Research Institute and Doctor Marino Molina, a Psychiatrist, are conducting a research study of an investigational medication for the treatment of Insomnia.

Each participant will receive at no cost:

Evaluations and medical exams related to the study, and study-related medications and you will also receive compensation for your time and transportation.

To see if you qualify for the Insomnia study, please call Amedica Research Institute today at (305) 681-7789.

Patient Inclusion Criteria:

1. Out-patients greater than or equal to 18 years of age
2. Women of childbearing potential must have a negative urine pregnancy test at screening - and must have a highly effective method of birth control for at least one month prior to screening
3. Diagnosis of primary insomnia based on criteria (DSM-IV-TR) with predominant complaints of difficulty 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

Inclusion Criteria for patients diagnosed with type II Diabetes Mellitus:

1. Patients with Type II Diabetes may be included if they have an established medical diagnosis of type II Diabetes Mellitus, 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)

Patient Exclusion Criteria:

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 caffeine 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 greater than or equal to 33 calculated from patient's height and weight
6. Use of any over-the-counter including tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication, including hypnotic and sedative, 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 know 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
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
11. History of primary hypersomnia, narcolepsy, breathing-related sleep disorders, circadian rhythm sleep disorder, parasomnia, dyssomnia not otherwise specified, i.e., periodic leg movement syndrome
12. Diagnosed with psychosis, bipolar disorder, OCD, MDD, anxiety disorders, panic disorders, eating disorders, and alcohol or substance abuse
13. History of epilepsy, seizures, or dementia
14. Any significant, severe or unstable, acute or chronically progressive medical or surgical condition
15. Any condition that may interfere how your body absorbs of the study drug, or may affect safety
16. Hepatitis B or Hepatitis C
17. Serious head injury or stroke within the past year

For More Information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.